Podcasts about fda approved

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Best podcasts about fda approved

Latest podcast episodes about fda approved

biobalancehealth's podcast
Healthcast 695 - The 17 Year Delay

biobalancehealth's podcast

Play Episode Listen Later Oct 16, 2025 16:21


See all the Healthcasts at https://www.biobalancehealth.com/healthcast-blog You will learn: What holds up new treatments for diseases and conditions How long the FDA sits on a known safe medical medication before it is released to the public. Why safe and effective drugs are NOT approved by the FDA Why doctors are forced to use medications off label How you can help During my 44 years of medical practice, I have encountered conditions for which there is no approved medication or surgical treatment available as recognized by the American College of OBGYN or the FDA. This situation can present challenges both for physicians managing these patients and for individuals seeking relief from their symptoms. This issue is not often addressed on Dr Oz, in the news, or at medical conferences. For many conditions, physicians wait for the development of approved medications or treatments, and in the meantime may inform patients that there is currently no treatment or cure available. Some doctors may attribute a patient's concerns to aging, stating that it is a universal experience. While this may be accurate, such explanations may not provide comfort to patients seeking solutions to their symptoms. This lack of helpful guidance can discourage individuals from seeking medical care when they feel their concerns are not acknowledged. This seems to result from insurance companies prioritizing cost savings by minimizing patient care.  Every year insurance companies decrease what they pay doctors for their services, while their expenses go up, and the Government requires more and more work behind the scenes like HIPPA, OSHA, and Clia requirements that costs more to deliver the same service.  If you have a problem with the time your doctor spends with you then blame the insurance companies whose profits rise every year…Soon doctors will do what I do and only take cash.  The practice of medicine is not working in a free market. While insurance limits the prescriptions of medication to those meds that are FDA Approved, the FDA and medical specialty colleges often delay approval of new, low-risk treatments for up to 20 years after their effectiveness is demonstrated. This lengthy process should be reconsidered to treat people who are ill and suffering, now. There is plenty of research in the medical journals that explain the safety of new and effective treatments that can save peoples' lives that are not FDA approved yet. The FDA is not interested in expediting the release of medication/ devices quickly to those people who need help now. They drag out the testing of a medicine that has been effective for years and may or may not approve it. On the flip side they have approved many drugs that later are found to have severe side effects, and they just change the warnings on the medication inserts. They don't take them off the market except in severe cases. Drugs that have worked treating patients successfully are being used but are not FDA approved. These “grandfathered drugs” don't need to go through the testing that new drugs go through because they work with few well-known risks. I use many if these medications because they are inexpensive for my patients and are often more effective than new meds for the same problem. One of the drugs that the FDA has not had to approve is Armour Thyroid, a natural thyroid replacement. My experience with treatments not approved by the FDA Armour Thyroid: Armour Thyroid (AT) has been prescribed by doctors to replace thyroid hormones for about 100 years. It is natural, made from Pig thyroid. It only comes from “medical Pigs” that are raised for medical purposes.  We use medical pigs for skin grafts, and other parts of the pig to treat human diseases like heart valve replacements.  Armour Thyroid is composed of the four thyroid hormones that humans make: T4, T3, T2, T1. The synthetic thyroid replacement, Synthroid/levothyroxine is only T4.  The active form of thyroid is T3, and it requires an enzyme to convert T4 into T3. If a person can't convert T4 into active T3 then nothing improves except the blood levels of T4, and TSH. The majority of women cannot convert T4 into T3. Therefore, if they take Synthroid or levothyroxine and their doctor only checks their TSH level and not the level of free T3 and free T4 to see if the Thyroid is working, then women are told that they are healed, yet they know they are not because none of their low thyroid symptoms are resolved. When this happens, doctors tell female patients that it is all in their heads and dismiss us when we tell them we are not cured with this synthetic T4 medication. Yet Synthroid is a chemical, and AT is natural from medical pigs, so the FDA is trying to Bann the only drug that has successfully treated millions of women. PS. Synthroid was not tested on women like many other drugs that were passed through the FDA before 2014! If you think this is a small problem, think again. Thyroid hormones are vital to human life, and the thyroid gland requires Iodine in the diet. The Midwest US has no Iodine in the soil or water. Therefore, this area is overburdened with hypothyroidism. I have been on AT for 50 years without complication and I have prescribed it thousands of times ever since I went into private practice.  AT works to relieve the symptoms of hypothyroidism for women and men, and it works better for women that the “new” drug Synthroid/levothyroxine, which is FDA approved. You ask how could the FDA approve a drug that doesn't successfully treat women? It is because Synthroid was not tested on women!  Until 2014 the FDA did not test women in the required drug trials.  AT works for us (women), Levothyroxine does not. Now the FDA wants to ban AT. It is not approved because it was around for decades before they started testing medications like they do now, and the history of successful treatment should stand on its own merit! Example 2: Bio-Identical Hormones BIH:  BIHs had not been approved by the FDA until recently and there was no announcement that they are now approved for women who have hormone deficiency symptoms or postmenopausal symptoms. Most doctors and women who have been afraid of the only hormones that can help them, bioidentical hormones, haven't yet been told that NOW, FINALLY the medical colleges and the FDA finally have quietly approved BI hormones.  There are no pure estradiol and pure testosterone pellets that are made by a drug company for women. My patients get their estradiol and testosterone pellets from a compounding pharmacy.  I have been prescribing BIH since 1985 without FDA approval because the oral estrogen formulations that were available at pharmacies caused weight gain and put women at high risk for blood clots. Non-oral BI hormones have fewer risks than FDA approved estrogens.  I waited more than 45 years for the FDA to approve BI hormones for treatment of women.  All those women in the last 45 years who were taking FDA approved estradiol and those who couldn't tolerate them have been harmed by FDA goals of never approving compounded or bio-identical hormones.  The delay has harmed 50% of American women. Example #3 Devices for Weight Loss I was involved in the discovery and testing of a unique device that stimulated acupuncture points with a TENS-unit-type patch connected to your cell phone for easy adjustment of your hunger or “fullness”. The FDA requires testing to approve any new device so the group of investors I was part of had to invest thousands of dollars for a device we already knew worked. The FDA told the investigators of all new devices who they should test, who they can't have in the study, and how long the testing should take. I found their parameters for the study of this device to be unrealistic. The women in our test group could not be taking hormones of any kind (birth control, ERT, HRT), and could not be on antidepressants, could not have diabetes or insulin resistance or be on any drug that assisted in weight loss. These women subjects had to be a certain BMI (level of obesity) and had to be tested repeatedly with weight and body composition measurements None of my patients who needed weight loss could participate.  Most GYN patients are on some medication or supplement, so the FDA made this study of our device so narrow that REAL WOMEN weren't tested! Sadly, we lost many women in the control group from the study because they were NOT losing weight while the ones on the device were obviously dropping pounds, so we had trouble maintaining test subjects. The testing phase of this simple device took 7 years! Our device works and no one will ever know about it or be able to use this non-medicinal weight loss device because when the FDA rejects your device you will be breaking the law if you produce and sell it directly to the public. It has no side effects or dangers..it just controls the amount you eat with stimulation of an acupuncture point. There are many ways to change this situation, and it takes years and billions of dollars to change the whole system of bringing treatments to patients quickly.  I'm afraid I won't see a revolution of the way we bring medicines and devices to market during my lifetime. Currently there is a 17-year delay between proving a drug or device works for a particular illness or condition and when it becomes available to doctors and patients. So what do we do in the meantime?  I seek treatments for patients who are unresponsive to traditional medicine by reading journals like Life Extension, that inform doctors and patients alike about new effective solutions for common medical complaints and diseases that the FDA has ignored or stymied with endless drug trials.  Life Extension Magazine highlights studies on new medications for diseases without an FDA approved solution and publicizes diagnostic tests often overlooked by mainstream publications because they are not yet FDA approved. The medical journals I read (New England Journal of Medicine, JAMA, Menopause, Metabolism and Endocrinology, Journal of Age management, to name a few) offer treatments for orphan diseases or even common problems that haven't been blessed by the FDA. It takes an average of 17 years from the culmination of research on a new drug, test or device until it is approved for use by the public! At the end of this Blog, I will give you a link to make your voice heard by signing a petition to shorten the approval of new treatments and medications from the average of 17 years to 3 years! My patients don't have time to wait for relief, and that may be the case for you as well. If you want to do something to help, please click this link and let the FDA know how you feel. Please sign a Petition to enact an amendment to the FOOD, DRUG and COSMETIC ACT, by going to: https://age-reversal.net/fda/

biobalancehealth's podcast
Healthcast 696 - Non FDA approved meds are prescribed by thousands of doctors every day

biobalancehealth's podcast

Play Episode Listen Later Oct 16, 2025 28:22


See all the Healthcasts at https://www.biobalancehealth.com/healthcast-blog If you ever doubted your doctor because she wrote a script that you later “Googled” and found was not FDA approved, I hope you trusted your doctor enough to realize that she wouldn't recommend any medication that would hurt you…. What is an unapproved use of a drug, also called “off-label”? Unapproved use of an approved drug is often called “off-label” use. This term can mean that the drug is: Used for a disease or medical condition that it is not approved to treat, such as when a chemotherapy is approved to treat one type of cancer, but healthcare providers use it to treat a different type of cancer. The drugs that are not approved by the FDA, yet are commonly used, have been used for decades before the 1964 law that required new drugs to go through extensive and very expensive testing before their release to the public. The operative word is NEW DRUGS AFTER 1964. Today I will talk about the safety of non-FDA approved drugs because they are: Older cheaper drugs used for many diseases and conditions before 1964 and are still used Drugs that are approved for one use, or one condition, but not for other conditions that it is effective and safe for. Drugs made by compounding pharmacies for diseases that the FDA has not approved a drug for, but there is research backing the drug and years of safe use. First, before we discuss the non-FDA approved drugs, I will discuss the safety/risks of FDA approved drugs, and why FDA approval doesn't mean a drug will do no harm or even that it is effective for the use it is approved for. A little background will help you understand the problem and the reason an FDA approval does not necessarily mean a drug is safe.  Since 1964, a law was passed that established testing prior to a drug being approved by the FDA became mandatory.   Since that time several drugs that survive FDA approval and are released but are later removed or banned after their FDA release when the public finds side effects that the FDA didn't discover in their trials. One such drug is Fen-Phen, Fenfluramine/Phentermine. This drug was released during my time practicing medicine and was withdrawn after one study claimed it caused heart valve disease…In the end the “one post approval study” that claimed that heart valves were affected by this drug that caused its bann was found to be false. The withdrawal of the drug followed one study by a single cardiologist from Kansas City had reviewed all of the cardiac valve echo tests and falsified the results to make Fen-Phen appear dangerous to heart valves, when in reality it wasn't.  She lost her license, but the FDA never put Fen-Phen back on the market!  The FDA hates to be wrong twice, so they never allowed this drug back on the market after its removal. Other mistakes made by the FDA include not allowing women in the studies to approve a drug before 2014 which ignores or misses all of the side effects or lack of effectiveness for a drug when taken by women.  Despite all the expensive testing before the release of a drug by the FDA, many drugs not tested on women were later often found to have severe side effects only on women. A few examples follow: You might have heard of the FDA approved drug Ambien that causes many women to experience “night eating”, sleepwalking, and night terrors, while their male counterparts were not affected, so because they only tested men the drug was approved. In retrospect it should have been tested on women as well, and then either not passed through the FDA or should have had a black box warning for women. It takes years get action from the FDA, notifying doctors of these side effects. Women were not included in testing for any drugs except female hormones until 11 years ago, but no other drugs.   Before 2014 all (non-hormonal) drugs that passed the FDA were not tested on women so the effect on women was unknown until it was tested on the public. The FDA left women out of drug-trials because it viewed women as “mini men”, or they didn't consider us important enough to test new drugs on…OR worse, they believed we were too complicated to easily test us because of pregnancy, menopause and other hormonal swings that normal healthy women have.  In any case, we are now suffering their decisions, when a medication works one way for men and another way for women! Finally, we are tested when drugs are being evaluated for approval by the FDA. Professional women have achieved a level of authority in medicine and pharmacology (2025) and are weighing in on the inequity. Women in the medical profession and the public are pulling back the curtain on the side effects of FDA approved drugs that are experienced by women only! Slowly, study by study investigators are now publishing the side effects and problems for women with FDA approved drugs….yet these findings are not included in the warnings on most of these drugs, even now over 15 year after they became obvious to the doctors who treat women! Drugs that either don't work for women, or that have severe side effects include that were approved before 2014. All statin drugs for high cholesterol (Crestor, rosuvastatin, atorvastatin, etc.) cause women to have muscle breakdown and muscle pain. Synthroid (levothyroxine), doesn't cure the symptoms of hypothyroidism in 80% of women, but just makes the TSH lower, so it appears as if it is working! This leads doctors to tell women that their symptoms are all in their heads!! Wrong.  It is the wrong medicine. Women have enzymes that differ from men that make it difficult for them to convert the inactive form (T4) into the active form (T3), so we can't convert Synthroid (all T4) into the active form. Synthroid, the FDA approved drug for hypothyroidism, shouldn't be given to most women. Women should be given the non-FDA approved drug Armour Thyroid or NP thyroid that have both T3 and T4 in them! Ambien Prednisone and other oral steroids We have reviewed the lack of testing on women before 2014, now we will discuss safe drugs that have been used for decades even before 1964 when the FDA required testing for FDA approval? Older, yet effective and inexpensive drugs have been tested by the public, some for almost 100 years that have saved thousands of lives, yet they are not given the FDA stamp of approval!  In fact, the FDA tries to put these drugs out of circulation, replacing them with very expensive drugs that are new! Or they just shut them down, because they are not FDA approved.  Young doctors are told not to use them by their medical schoolteachers who rarely have experienced these medications in private practice…. These doctors in training don't know the history of older safer, cheaper drugs, or even why the FDA tells them avoid them. They comply not knowing why, so you are left with no drug that works for you, or you pay 3-10 times the amount for a newer FDA version of the older drug which may even have more side effects. Some of these older very effective and cheap drugs are Penicillin, Nitroglycerine for chest pain, Morphine (pain), Phenobarbital (seizures), Codeine, Armour Thyroid, hormone injections including estradiol injections and testosterone, Thorazine for psychiatric use, (Pitocin) oxytocin for labor, lactation support and Autism Colchicine:Used to treat and prevent gout. Progesterone in oil (IM) Estradiol in oil (IM) B12 for injection Testosterone Cypionate for injection Compounded Estradiol in any form Compounded Testosterone for women These drugs have been used for so long that any safety risks or side effects have been found through the use of these drugs in the population. Yet the FDA won't grandfather them in and approve them based on their history! What do doctors do when the drug the FDA has approved a drug that doesn't work for a group of their patients (gender, race, blood type, etc.)?  What happens when a doctor can't find a drug that is FDA approved needed to treat a condition she is faced with? Why do we as citizens, allow the government to have power over doctors who are already controlled by their state licensing boards as to what medications they?  Lastly Why do taxpayers allow a government agency that they fund with tax dollars control their health by banning, or not approving drugs, or banning one drug so an outrageously expensive drug is put in its place? Compounded Medications/ Compounding Pharmacies: These drugs are made by mixing ingredients to meet individual patient needs and are not subject to premarket review for safety, effectiveness, or quality. However, they ARE subject to the success or failure for which they were prescribed. If a doctor prescribes a compounded drug that doesn't work, she is apt to be confronted by her patient who is not getting the expected results.  Compounding pharmacies usually don't get paid by insurance, so patients are more invested in getting a drug that works and that is one of the big reasons that Compounded medicines are at least as good or better than big pharma or generic drugs. I absolutely could not successfully treat the thousands of women and men that I have without compounding pharmacies.  They compound hormones/drugs that are safe and effective, mostly hormones that can't be patented because they occur in nature and won't ever be made by big pharma. More than that, big producers of drugs can't produce in mass quantities many doses of a certain hormone like compounding pharmacies do.  Compounding pharmacies provide what people need and they continue to do so because patients prefer their dosing and quality.  FDA approved Generic Drugs can be legally 25 % lower dose than what they say they are.  That would be a big problem if my compounded pellets had that kind of variability. People might need pellets every 2months or every 5 months instead of every 4 months..it would be like guessing what you need ahead of time…..I believe dedicated compounding pharmacists are more accurate than any generic on the market. Compounding pharmacies: Unsung Heros Compounding pharmacies serve the public when big pharma fails and hasn't developed a safety net for production if they have a problem and the FDA shuts them down. That situation leaves patients who take their medications, without an alternative. Compounding pharmacies step into the breech when big pharma has a problem with a particular drug and stop making a drug (e.g. Lidocaine, B12 injectable, IV Fluids, to name a few shortages and no production that have occurred in the recent past). What if patients couldn't get the meds they need, and if there were no compounding pharmacies—Chaos and suffering and dying patients would closely follow! The FDA is Fickle and is not on your side! For years the FDA did not approve of Bioidentical estrogen and testosterone in any form, and just a few months ago all of a sudden, long after they scared women from taking the hormones they needed to improve their length of life and quality of life, they decided bioidentical hormones are better than the FDA approved hormones!!!  That is a little too late.  Some of us will never forget the stress lack of approval of compounded hormones caused for doctors and patients alike.  Other doctors criticized us and now most of them aren't even in practice anymore.  Maybe the FDA read my blog!!! Compounded hormones have been approved by the masses of women who have taken them under my signature! Compounded BI hormones are medications with a long track record and should not have to be tested with the bloated expense required of testing for the FDA. For Gynecological Disorders that don't have an FDA approved hormone drug because testosterone and estradiol have been used for so long that they don't need testing. If there was a significant problem with them their history of use of over 5-7 decades has proven the efficacy and safety of the female hormones for treatment and hormone replacement. For Psychiatric Disorders: Some patients need compounded ketamine products for conditions like severe depression, despite lacking FDA approval for these uses and potential risks, yet it has been used for this purpose for decades and was used for childbirth for almost a century, until epidurals and saddle blocks took their place. Testosterone for women still is not recognized as a female hormone even though women produce over twice as much Testosterone as Estradiol when they are in their fertile years.   Replacement of T with bioidentical T pellets offers a treatment for dozens of symptoms women face after age 40, and it prevents the diseases of aging: osteoporosis, heart disease, sarcopenia, frailty, diabetes and more that have not been addressed by mainstream medicine and the FDA. Over a decade ago, the FDA turned down the approval of testosterone patch after over 3 years of positive research studies, the FDA said they didn't approve T for women is because the side effect of T for women, facial hair, was dangerous for women.…I cry B—–S—-!  That is really men not wanting to share testosterone replacement with women. I say leave us alone and let women and their doctors determine what they need.  It is proven that only 5% of all professionals in any profession are not trustworthy, so give doctors their due and trust that we are looking for answers to our patients' problems that you don't even know about! The FDA is paid for by us…everyone in this country. I say hands off! Speed up the approval process or forget it for older drugs and BI hormones! ~

The WorldView in 5 Minutes
Trump's FDA approved a new Abortion Kill Pill, Cuba sends 5,000 troops to aid Ukraine despite grinding poverty, Nigerian military opened fire on Christians

The WorldView in 5 Minutes

Play Episode Listen Later Oct 7, 2025


It's Tuesday, October 7, A.D. 2025. This is The Worldview in 5 Minutes heard on 140 radio stations and at www.TheWorldview.com.  I'm Adam McManus. (Adam@TheWorldview.com) By Kevin Swanson Nigerian military opened fire on Christians Christian persecution at the hands of Muslim terrorists in Nigeria was tough enough. Now, Truth Nigeria reports that the Nigerian military has opened fire on Christians in the Benue State — this time killing three young men. Ten others sustained life-threatening gunshot wounds and are receiving medical treatment in Jato-Aka. The local chief said, “We no longer need the military in our land. … They have joined Fulani to kill us and take over our land. They have turned their guns against us. … The betrayal is unbearable. Enough is enough. President Tinubu and Governor Alia should hear this message and take immediate action.” Newsweek urges State Dept to declare Nigeria “Country of Particular Concern” Newsweek.com has joined the voices of comedian Bill Maher and others, pointing to the egregious level of Christian killings in Nigeria. The Nigerian government has “categorically” denied that terrorists are waging a systematic genocide against Christians in the country. Newsweek noted that the Trump State Department has thus far failed at making Nigeria a “Country of Particular Concern.” Europe's swirling politics France just lost its third prime minister in about a year. Sébastien Lecornu was the latest, and he just resigned yesterday after only 27 days in office. This marks the most instability for the French government in 70 years. France's nationalist, anti-immigration party increased from obtaining 4% of parliamentarian seats in 2008 to 37% in 2024. Germany lost its government earlier this year.  Germany's anti-immigration party is supported by 24% of the country, up from virtually nothing ten years ago.  And Portugal faces instability, still run by a minority government, having completed its third election in three years in May.  Portugal's nationalist party increased from half percent in 2019 to 23% in the 2025 elections. Also, the Netherlands, Sweden, Finland, and Italy have experienced wide swings in governance — shifting to a nationalist position over the last 5-10 years. Daniel 2:21 reminds us that it is God who “changes times and seasons; He removes kings and sets up kings; He gives wisdom to the wise and knowledge to those who have understanding.” Cuba sends 5,000 troops to aid Ukraine despite grinding poverty Reuters reports that Cuba is supporting the Ukrainian War now with up to 5,000 troops. The communist country's economy is lagging badly — suffering a four-year decline in its Gross Domestic Product, with another decline forecasted for this year, reports InDepthNews.com. Inflation is running at 28%. The nation has suffered at least five energy blackouts this year so far.  And 89% of the populace suffers from “extreme poverty” according to a recent survey. Seven out of ten Cubans have stopped eating breakfast, lunch, or dinner due to lack of money or food shortages. Only 15% have been able to eat three meals a day without interruption. That compares with the next poorest countries in Central America. Just 16% of Guatemalans  and 27% of folks in Honduras have to deal with these levels of extreme poverty. Supremes consider Trump's tariffs, Hawaii's gun restrictions, &  trans sports As the US Supreme Court reconvenes, the docket holds a slew of cases. They include the legitimacy of the Trump Tariffs, the president's removal of high level administrative bureaucrats, Colorado's ban on counselors helping minors out of homosexual sin, Hawaii's gun restrictions, and bans issued by red states on boys pretending to be girls playing in girls' sports in public schools.  Trump's FDA approve a new Abortion Kill Pill The Trump Administration's Food and Drug Administration approved another abortion kill pill to accommodate the killing of children in their mother's wombs. Last week, the FDA approved Evita Solutions' generic abortion drug for the US market. This is hardly in line with the administration's pledge to “review all the evidence—including real-world outcomes—on the safety of the drug” issued just last month. Ostensibly, the big concern is the health of the mother. The FDA reports 36 deaths attributed to the abortion kill pill thus far, but 7.5 million murdered babies. 63% of the annual abortions committed in the country today are attributed to the abortion kill pill.  Isaiah 29:15-16 speaks to this. The prophet wrote, “Woe to you who hide deep from the Lord your counsel, whose deeds are in the dark, and who say, “Who sees us? Who knows us?” You turn things upside down! Shall the potter be regarded as the clay, that the thing made should say of its maker,  “He did not make me”; or the thing formed say of him who formed it, “He has no understanding”? Mt. Everest hiker died, 200 others stranded in shock blizzard And finally, one hiker has died and 200 others are still stranded in a shock blizzard on Mount Everest over the weekend. The blizzard took about 1,000 hikers by surprise.  Thus far this year, five people have died on Everest. Last year's total was eight, and 18 others died on the treacherous slopes in 2023. About 800 people attempt to summit the tallest mountain in the world each year. Close And that's The Worldview on this Tuesday, October 7th, in the year of our Lord 2025. Follow us on X or subscribe for free by Spotify, Amazon Music, or by iTunes or email to our unique Christian newscast at www.TheWorldview.com.  I'm Adam McManus (Adam@TheWorldview.com). Seize the day for Jesus Christ.

The Skeptics Guide to Emergency Medicine
SGEM Xtra: Tell Me Lies, Sweet Little Lies – FDA Approved & Ineffective

The Skeptics Guide to Emergency Medicine

Play Episode Listen Later Sep 14, 2025 52:11


Date: August 12, 2025 Article: FDA Approved and Ineffective by Jeanne Lenzer and Shannon Brownlee. June 5, 2025. The Lever. Guest Skeptic: Jeanne Lenzer is a long-time medical investigative journalist and returning SGEM guest. Her previous work, including the book The Danger Within Us, explored how conflicts of interest and weak evidence can endanger patient care. In […] The post SGEM Xtra: Tell Me Lies, Sweet Little Lies – FDA Approved & Ineffective first appeared on The Skeptics Guide to Emergency Medicine.

Proactive - Interviews for investors
Tonix showcases Phase 3 data for FDA-approved Tonmya at PAINWEEK 2025, eyes launch next quarter

Proactive - Interviews for investors

Play Episode Listen Later Sep 12, 2025 5:16


Tonix Pharmaceuticals Holdings CEO Dr Seth Lederman joined Steve Darling from Proactive to share that the company presented four scientific posters at the PAINWEEK 2025 conference in Las Vegas, Nevada, showcasing robust data from two pivotal Phase 3 trials of Tonmya® for the treatment of fibromyalgia. The first study, RELIEF, was a 14-week randomized, double-blind, placebo-controlled trial, while the second, RESILIENT, served as a confirmatory efficacy and safety trial. Results across both studies demonstrated that Tonmya significantly reduced fibromyalgia-related pain while maintaining a favorable tolerability profile. Unlike conventional pain therapies, Tonmya is designed to pharmacologically target nonrestorative sleep by antagonizing receptors that regulate sleep architecture—addressing a central mechanism thought to perpetuate fibromyalgia symptoms. Dr. Lederman noted that beyond reducing pain, Tonmya's mechanism of action may help improve a wide spectrum of fibromyalgia symptoms, potentially supporting earlier diagnosis, timely intervention, and improved long-term outcomes. Importantly, the therapy represents a non-opioid treatment option at a time when safer alternatives are in high demand. With FDA approval secured, Tonix is now preparing to launch Tonmya commercially in the coming quarter, marking a transformative milestone for both the company and the fibromyalgia community. #proactiveinvestors #tonixpharmaceuticalsholdingcorp #nasdaq #tnxp #Biotech #TonixPharmaceuticals #Tonmya #Fibromyalgia #FDAApproval #NonOpioid #PainManagement #ChronicPain #NociplasticPain #Cyclobenzaprine #MoveFibroForward #Painweek2025

Engadget
Is Microsoft planning to use Anthropic models to power some of Office 365's Copilot features? Plus, the FDA approved human trials for pig kidney transplants

Engadget

Play Episode Listen Later Sep 10, 2025 8:30


Microsoft reportedly plans to begin using Anthropic's latest Claude models to power some of the Copilot features in its Office 365 apps. In a report published Tuesday, The Information said the tech giant would announce the change "in the coming weeks." Microsoft currently relies on OpenAI's tech to power the majority of AI features found inside of Word, Excel, Outlook and PowerPoint. Also, the FDA approved the biotech company eGenesis to begin human trials of pig-to-human kidney transplants. eGenesis provides pigs with CRISPR-modified genes. These genetic changes reduce the chances of organ rejection in human recipients. Learn more about your ad choices. Visit podcastchoices.com/adchoices

Intelligent Medicine
Leyla Weighs In: Advances in Alzheimer's Detection and Prevention

Intelligent Medicine

Play Episode Listen Later Sep 5, 2025 23:59


Nutritionist Leyla Muedin discusses recent advancements in the detection and prevention of Alzheimer's disease. Topics include the new FDA-approved Lumipulse blood test, the role of a ketogenic diet in improving mitochondrial health, and the significance of lifestyle changes such as social and cognitive activities. The episode also highlights promising research from the University of California Irvine on using natural compounds like nicotinamide and EGCG to rejuvenate aging brain cells and address the buildup of Alzheimer's-associated proteins. Leyla also provides insights into the difference between Alzheimer's and general dementia and emphasizes the importance of accurate diagnosis and appropriate treatments.

The Dr. Haley Show
115 | The Truth About Red Light Therapy with Steve Marchese

The Dr. Haley Show

Play Episode Listen Later Aug 29, 2025 60:07


Steve Marchese, the CEO of LightStim, the largest LED Medical Device Manufacturer in the US, shares insights, truths, and myths regarding the benefits of true "light stimulation". Steve Marchese joins Dr. Haley to discuss how what people call "red light therapy" is more than just one color. It also includes blue and infrared, which are crucial for seeing full benefits. Listen to the full podcast to learn more about these alternative therapies.RESOURCES:https://drhaley.com/truth-about-red-light-therapy/https://lightstim.com/https://www.facebook.com/lightstimhttps://www.instagram.com/lightstimhttps://www.linkedin.com/company/lightstim/https://www.youtube.com/LightStimTIMESTAMPS:00:00 Intro Snip00:33 Coupon Announcement for use at Lightstim.com02:38 Introduce Steve Marchese CEO of Lightstim04:02 Why "light therapy" should be called "light stimulation"04:33 What is light therapy and light stimulation used for?07:52 Do you treat just the injury with light stimulation or the whole body when there is an injury?11:22 How can you tell if you are buying a quality light therapy device and if it does what it is supposed to do?13:48 What is the difference between FDA Registered and FDA Cleared or FDA Approved?15:25 How can we use multiple wavelengths at the same time without cancelling out the wavelengths?18:00 How close should you be to the LED light source for efficacy?20:10 What happens when you use an acrylic layer for the patient to lay on?21:58 What is the FDA's test for efficacy?26:00 What did the FTC warn the health and wellness industry about red light therapy?27:22 What did a law firm do recently regarding an FDA "EXEMPTION" in January of 2021?28:25 What did the "FDA Exemption" actually require?30:00 What were the 2 additional requirements to qualify for the exemption?33:16 What is the difference between red laser treatment and red led treatments?35:20 What makes red light the right color and wavelength?37:17 What do the infared radiators in the sauna tent do?40:40 Does insurance pay for light stimulation?41:10 How does light stimulation affect blood pressure?43:04 Where can we go to try one of the red light stimulation beds?44:24 Us there a difference in the output between battery and corded handheld units?46:31 Where are the LightStim products manufactured?49:15 Where should people go for more information?50:15 What are some of the myths of red light therapy?52:25 What are the general principles between using red, blue, and amber?56:40 How to use an aloe vera leaf for anti-aging57:25 How to use a lightstim unit to improve the performance of skin products

GRUFFtalk How to Age Better with Barbara Hannah Grufferman
REPLAY: FDA-Approved Osteoboost - Why I Started Using This NASA-Inspired Bone Health Device EP 165

GRUFFtalk How to Age Better with Barbara Hannah Grufferman

Play Episode Listen Later Aug 26, 2025 43:49


RESOURCES & LINKS  Watch a message from Barbara HERE  Check out the Osteoboost Official Website HERE  Visit the Bone Health & Osteoporosis Foundation Website HERE  EPISODE UPDATE This is a replay of our March episode with Laura Yecies, CEO of Osteoboost. Since our original conversation aired, I have started using the Osteoboost vibration belt—30 minutes daily—as part of my bone health routine.  In this conversation, Laura and I discuss Osteoboost, an FDA-approved device using NASA-inspired vibration therapy to combat bone loss. Laura explains how the technology works, its impressive clinical results (85% reduction in spinal bone loss), and who benefits most.  KEY TAKEAWAYS  Early intervention in bone health is crucial; hip fractures pose significant risks  Osteoboost uses precision vibration technology inspired by NASA research  The device works best when combined with nutrition and exercise  Particularly effective for postmenopausal women with osteopenia  FDA-approved and backed by clinical studies showing microarchitectural improvements  Telehealth options are available for prescriptions  Future studies planned for osteoporosis applications  Note: For informational purposes only. Consult your healthcare provider before starting any new health regimen.  Take a listen—and don't forget to follow the show so you never miss an episode.    If you're enjoying Age Better, I'd be so grateful if you left a quick review wherever you listen.     And if there's a topic or question you'd love for me to cover in a future episode, send a note to agebetterpodcast@gmail.com -- I love hearing from you!   Learn more about your ad choices. Visit megaphone.fm/adchoices

That Plastics Guy
Tech Tip Friday - FDA Approved vs Compliant

That Plastics Guy

Play Episode Listen Later Aug 22, 2025 3:27


In today's TTF, Kurt talks about the differences between FDA approved resins and those that are FDA compliant.  Save money where you can!Find Simcoe Plastics Ltd. on Facebook and Instagram. Find "That Plastics Guy" on Linked-In and YouTube. Find Kurt Stahle on Linked-In as well.Subscribe to our newsletter at www.simcoeplastics.comAll links here https://linktr.ee/kurt_stahle

Whitening Wednesday Podcast
#76 FDA "Approved" Teeth Whitening Gels

Whitening Wednesday Podcast

Play Episode Listen Later Aug 18, 2025 9:12


There's a big difference between FDA approval, registration, and compliance—and most whitening reps don't get it. This week's episode breaks down the facts behind the label and why “approval” might actually be a red flag. 00:00 – Intro: “Are my gels FDA-approved?” Trend or truth? 01:01 – Cosmetic vs dental gels: what you can (and can't) use 02:10 – The red flag of “FDA approved” claims 03:20 – Medical-grade gels vs cosmetic scope (the real difference) 04:15 – Rach's “Ask Them” theory – get receipts or walk away 05:08 – What FDA & Health Canada actually regulate 06:04 – Facility standards, compliance & why your gel is still safe 07:05 – What to actually ask your supplier instead of “FDA approval” 07:55 – Why overselling “FDA approved” makes you look sketchy 08:30 – Final mic-drop: Stop the false trends Thank you to our sponsor Fern Whitening Supplies.

Oncotarget
FDA-Approved MI Cancer Seek Test Enhances Tumor Profiling for Precision Oncology

Oncotarget

Play Episode Listen Later Aug 15, 2025 4:13


BUFFALO, NY – August 15, 2025 – A new #research paper was #published in Volume 16 of Oncotarget on August 13, 2025, titled “Clinical and analytical validation of MI Cancer Seek®, a companion diagnostic whole exome and whole transcriptome sequencing-based comprehensive molecular profiling assay.” In this study, first authors Valeriy Domenyuk and Kasey Benson, along with corresponding author David Spetzler from Caris Life Sciences in Irving, Texas, introduce MI Cancer Seek, an FDA-approved test designed to deliver comprehensive tumor profiling. MI Cancer Seek demonstrated strong concordance with other FDA-approved companion diagnostics and serves as a powerful tool to guide treatment decisions in both adult and pediatric cancer patients. Cancer remains one of the most complex and diverse diseases to treat. With many targeted therapies currently FDA-approved, selecting the right one for a specific patient requires detailed genetic insights. MI Cancer Seek addresses this need by analyzing both DNA and RNA from a single tumor sample. The tool identifies key biomarkers linked to FDA-approved treatments for several major cancers, including breast, lung, colon, melanoma, and endometrial cancers. One of the most significant strengths of MI Cancer Seek is its ability to deliver accurate and reliable results from minimal tissue input (50 ng). Even when analyzing formalin-fixed paraffin-embedded samples, which are widely used but often degraded, the test maintained high levels of accuracy. It successfully detected important genetic alterations such as PIK3CA, EGFR, BRAF, and KRAS/NRAS mutations and measured tumor mutational burden (TMB) and microsatellite instability (MSI), both of which are key indicators for immunotherapy response. In clinical comparisons, the test achieved over 97% agreement with other FDA-approved diagnostic tools, confirming its reliability in detecting critical biomarkers. Notably, it showed near-perfect accuracy in identifying MSI status in colorectal and endometrial cancers. The researchers also demonstrated that the test maintains precision across different lab conditions and varying DNA input levels, confirming its robustness for routine clinical use. Beyond its role as a companion diagnostic, MI Cancer Seek incorporates additional features developed under its predecessor, MI Tumor Seek Hybrid. These include detection of homologous recombination deficiency, structural variants, and cancer-related viruses. It also includes advanced tools such as the Genomic Probability Score for identifying the tissue of origin in cancers of unknown primary, as well as a gene signature to guide first-line chemotherapy in colorectal cancer. “One limitation to be considered is the low PPA for ERBB2 CNA detection.” By offering deeper genetic insights from a single, small sample, MI Cancer Seek has the potential to streamline diagnostics, reduce testing costs, and connect patients to effective therapies more quickly. As precision medicine continues to expand, this assay stands out as a comprehensive and efficient solution for meeting the evolving needs of modern oncology. DOI - https://doi.org/10.18632/oncotarget.28761 Correspondence to - David Spetzler - dspetzler@carisls.com Video short - https://www.youtube.com/watch?v=D4hd2FxCYY8 Subscribe for free publication alerts from Oncotarget - https://www.oncotarget.com/subscribe/ To learn more about Oncotarget, please visit https://www.oncotarget.com and connect with us: Facebook - https://www.facebook.com/Oncotarget/ X - https://twitter.com/oncotarget Instagram - https://www.instagram.com/oncotargetjrnl/ YouTube - https://www.youtube.com/@OncotargetJournal LinkedIn - https://www.linkedin.com/company/oncotarget Pinterest - https://www.pinterest.com/oncotarget/ Reddit - https://www.reddit.com/user/Oncotarget/ Spotify - https://open.spotify.com/show/0gRwT6BqYWJzxzmjPJwtVh MEDIA@IMPACTJOURNALS.COM

Healthy Vitals
Smoking Cessation: Evidence-Based Insights on common NRT, new FDA approved Zyn Nicotine Pouches vs. Vaping

Healthy Vitals

Play Episode Listen Later Aug 15, 2025


Dr. Aliaksandr Ramaniuk and Nicole Piriak discuss the importance of smoking cessation, the dangers of vaping, and various replacement therapies. 

Let's Talk Quality
Megan Callan on Leading Quality at Abeona to it's First FDA-Approved Therapy

Let's Talk Quality

Play Episode Listen Later Aug 13, 2025 46:15


In today's episode, I was joined by Megan Callan, Vice President of Quality at Abeona Therapeutics.I really wanted to speak to Megan because her last few years at Abeona have been a masterclass in building a quality organisation that can handle the demands of commercial manufacturing - all while driving a digital transformation and keeping a patient-first mindset.Megan has a unique career journey, moving across different industries and company sizes, and in this conversation, she opens up about how she's navigated the shift from tactical to strategic leadership, what it takes to scale a quality team rapidly, and how AI is already influencing the role of QA.We talk about the following:

Dr. Joseph Mercola - Take Control of Your Health
The FDA Approved Drugs That Don't Work - AI Podcast

Dr. Joseph Mercola - Take Control of Your Health

Play Episode Listen Later Jul 9, 2025 7:11


Story at-a-glance Results of a two-year investigation found that the U.S. Food and Drug Administration (FDA) approved nearly 75% of new drugs between 2013 and 2022 without meeting its own basic standards Some cancer and Alzheimer's drugs were fast-tracked using surrogate markers like tumor shrinkage or protein levels, not real improvements in survival, memory, or function Dangerous side effects — including brain inflammation, hemorrhage, and blindness — were linked to drugs approved on minimal or flawed data, with thousands of deaths occurring each year The reporters created a searchable database on FDA drug approvals made between 2013 and 2022 — use it to check if any of your prescriptions meet the four scientific standards Always ask if a drug shows real-world benefits, look up its approval history, wait on new drugs, review your prescriptions, and work with a doctor who questions the system

Psychopharmacology and Psychiatry Updates
Naltrexone vs. Topiramate: FDA-Approved vs. Off-Label Options for MAUD

Psychopharmacology and Psychiatry Updates

Play Episode Listen Later Jun 30, 2025 10:07


In this episode, we explore groundbreaking head-to-head research comparing topiramate and naltrexone for alcohol use disorder, revealing surprising equivalence in effectiveness. Could the off-label option actually be as good as our FDA-approved standard for treating problematic drinking? Faculty: David Gorelick, M.D. Host: Richard Seeber, M.D. Learn more about our membership here Earn 0.5 CME: Quick Take Vol. 69 Can Topiramate Replace FDA-Approved Medications for Alcohol Use Disorder?

Chicago's Afternoon News with Steve Bertrand

Dr. Sterling Elliott, clinical pharmacist at Northwestern Medicine and assistant professor of orthopedics at Feinberg School of Medicine, joins Lisa Dent to discuss ivermectin. Dr. Elliot explains, is prescribed to treat parasitic infections. He shares when its prescribed, and whether or not ivermectin is FDA approved.

Digital Pathology Podcast
141: Digital Pathology Tools: FDA Approved

Digital Pathology Podcast

Play Episode Listen Later Jun 9, 2025 18:55 Transcription Available


Send us a textWhy do so many digital pathology tools stall before they ever reach patients? In this USCAP 2025 special sponsored by Muse Microscopy, I talk with Esther Abels, founder of SolarisRTC, regulatory strategist, and the force behind the first FDA-cleared whole slide imaging system.We break down what startups and established companies must do from day one to succeedbin getting their devices through the FDA. Hint: regulatory strategy isn't a final step—it's your starting line.

OstrowTalk
[Blog] New FDA-Approved Non-Opioid Medication Targets Pain

OstrowTalk

Play Episode Listen Later May 28, 2025 4:35


This blog was created using Notebook LM.This podcast describes the FDA approval of Suzetrigine, a novel non-opioid medication intended for moderate to severe pain. It explains that Suzetrigine operates by inhibiting voltage-gated sodium channel 1.8, which are crucial for transmitting pain signals. 

Pushing The Limits
Osteoboost's FDA-Approved Solution for Osteopenia and Osteoporosis with Laura Yecies

Pushing The Limits

Play Episode Listen Later May 22, 2025 35:57


In this enlightening episode, we sit down with Laura Yecies to discuss Osteoboost, the first and only FDA-cleared, drug-free prescription medical device designed to treat osteopenia in postmenopausal women. Dr. Yecies shares insights into the clinical research behind Osteoboost, its development inspired by NASA-funded studies, and the importance of proactive bone health management. Key Topics Covered: The Innovation Behind Osteoboost: Understanding how precision vibration therapy targets the spine and hips to reduce bone density and strength loss. (Osteoboost) Clinical Efficacy: Discussing the results from a double-blind, placebo-controlled clinical trial showing up to an 85% reduction in spine bone density loss and an 83% reduction in bone strength loss among consistent users. (MedicalEconomics) Importance of Early Intervention: Exploring why addressing bone health before the onset of osteoporosis is crucial, especially for postmenopausal women. User Experience: Highlighting the ease of incorporating Osteoboost into daily routines, with just 30 minutes of use per day during activities like walking or cooking. (MedicalEconomics) Broader Implications: Considering how Osteoboost fits into the larger conversation about aging, mobility, and long-term health. Resources & Links: Learn more about Osteoboost: Osteoboost Clinical Trial Details: Osteoboost Clinical Trial Results FDA Clearance Information: FDA Grants Clearance to Bone Health Technologies' Wearable Device for Osteopenia Guest Bio: Laura Yecies is the CEO of Osteoboost Health, Inc., the company behind the first and only FDA-cleared, non-drug wearable for low bone density. She has over 30 years of leadership experience in the technology and medical sectors. Prior to Osteoboost, she was CEO of NeuroSync, Catch (acq. by Apple), and SugarSync. Laura is also an active advisor and executive coach for early-stage digital health and therapeutics companies, focusing on supporting women founders. She holds an MBA from Harvard, MSFS from Georgetown, and AB from Dartmouth.

The Nutritional Therapy and Wellness Podcast
Ep 043: Lab-Grown Meat Drugs and Bugs - The FDA-Approved "Science" You Just Ate

The Nutritional Therapy and Wellness Podcast

Play Episode Listen Later May 20, 2025 64:01


Eating crickets and meat grown in a lab with cancer-like cells - WHO APPROVED THAT?! Scott Tips, president of the National Health Federation (NHF) and internationally recognized health freedom attorney, joins host, Jamie Belz, to help us understand the deeper mechanisms of Codex Alimentarius, the World Trade Organization (WTO), and the global regulatory web that threatens access to nutrient-dense food, natural health remedies, and therapeutic supplements.   As the only health-freedom organization with official INGO (International Non-Governmental Organization) status at Codex, NHF is uniquely positioned to stand up for the public's right to safe, informed, and autonomous healthcare choices on the global stage.   Over the last 70 years, NHF has defended medical choice and challenged the federal government's overreach into nutrition, supplementation, and holistic healing.   Some quick topics/snippets from this episode: Codex creates international food law—affecting everything from vitamin dosage limits to whether or not your meat contains drug residues. Most people don't even know Codex exists. And yet, decisions made there determine what shows up in your grocery cart, your supplement bottle, and your child's plate. The U.S. can now force genetically modified foods into countries that don't want them — not through diplomacy, but through international tribunals using Codex standards as their weapon. Ractopamine is a drug with zero therapeutic value. It makes animals fatter, faster — but it's banned in the EU, China, and Russia. In the U.S., you're probably eating it. When you hear ‘scientific consensus,' be cautious. The phrase is used to bulldoze public concern. You can be banned for calling out corruption at Codex. At CODEX, NHF is the only one defending your right to natural health freedom. The EU, Russia, even Iran — they've stood up for consumer safety at Codex more than the U.S. delegates have. The scary thing isn't just what the FDA is doing. It's how many people still trust them, blindly — even when their actions have harmed more people than every U.S. war combined. We need advocacy from the ground up. Most parents feeding their kids toxic food don't even know it — because the truth has been buried. “Frankenmeat”, insect protein, and natural flavoring cover-ups, all of which bypass transparent labeling laws while being quietly introduced into the food supply. They're trying to outlaw homeopathy—while promoting lab-grown meat and insect protein as sustainable alternatives. We don't want to be right. We want to get it right.   “Unless we put medical freedom into the Constitution, the time will come when medicine will organize into an undercover dictatorship… To restrict the art of healing to one class of men and deny equal privileges to others will constitute the Bastille of medical science. All such laws are un-American and despotic.” - Dr. Benjamin Rush, Declaration of Independence signator and Surgeon General of the Continental Army   "If people let the government decide what foods they eat and what medicines they take, their bodies will soon be in as sorry a state as the souls of those who live under tyranny.” - Thomas Jefferson   TAKE ACTION:  Join the National Health Federation for only $45/year to support international advocacy at Codex and receive the quarterly NHF magazine. This low-cost membership helps fund independent watchdog efforts that no other organization is legally authorized to perform at the global level. ⁠JOIN HERE⁠   Other mentions: ⁠⁠Ep 034: Fight For Your Right To Health Freedom⁠⁠ ⁠The HighWire report exposing Peter Marks and vaccine data suppression⁠    Health freedom is necessary. As government and corporate interests grow more entangled, grassroots advocacy is no longer optional. It's essential. Join the NHF and become part of the movement to reclaim sovereignty over what we eat, how we heal, and what we're allowed to know.    

The Guy Gordon Show
New FDA-Approved Blood Test for Colon Cancer Screening

The Guy Gordon Show

Play Episode Listen Later May 20, 2025 8:06


May 20, 2025 ~ A new FDA-approved blood test, the Shield test, is available for colon cancer screening for people 45 and older. Guardian VP of Clinical Development, Dr. Sam Asgarian, talks with Lloyd, Jamie, and Chris about this alternative test to traditional methods and simplifying the screening process.

Swineweb.com
Matt Culbertson Joins Us: Inside PIC's Historic FDA-Approved PRRS-Resistant Pig

Swineweb.com

Play Episode Listen Later May 15, 2025 6:48


How Gene Editing Could Transform Global Pork HealthJoin us for an exclusive conversation with PIC as we explore the historic FDA approval of the first gene-edited PRRS-resistant pig. Discover what this milestone means for the future of pork production, how gene editing differs from traditionalGMOs, and why this matters for both producers and consumers. We also dive into the potential $1.2 billion impact on global herd health and what's next as PIC plans for a responsible international rollout.

Doc Talk: Beverly Hills
Illegal Silicone Injections vs. FDA-Approved Silicone Implants

Doc Talk: Beverly Hills

Play Episode Listen Later Apr 23, 2025 19:44


In this episode of Plastic Surgery 90210, Dr. J. Timothy Katzen and Ariel 90210 break down the critical differences between illegal silicone injections (also known as “butt shots” or “permanent filler”) and FDA-approved silicone implants used in plastic surgery. Learn why free silicone injections are extremely dangerous, how they can migrate through the body, and the life-threatening complications they cause—from silicone embolism to kidney failure.Dr. Katzen shares real patient stories, including tragic cases of underground injections gone wrong, the formation of scar tissue (bobas), and why liquid silicone cannot be safely removed. The discussion also covers safer alternatives for buttock enhancement, including BBLs, butt implants, Sculptra, and FDA-approved fillers.

Rohrich Knose
Letybo: The New FDA-Approved Neuromodulator from Korea

Rohrich Knose

Play Episode Listen Later Apr 17, 2025 12:33


In this episode, Dr. Rohrich is joined by Dr. Steven Faigan to discuss Letybo, the newest FDA-approved neuromodulator from Korea.

DiversifyRx
FDA-Approved 'Ycanth': A New, Precise Treatment for Molluscum Contagiosum | Becoming A Pharmacy Badass

DiversifyRx

Play Episode Listen Later Apr 5, 2025 11:58


*In this Episode, Dr. Lisa Faast discusses the FDA-approved product Ycanth, the only approved cantharidin treatment for molluscum contagiosum.** **Show Notes:** 1. **Introduction to the Podcast and Lisa Faast** [0:00] 2. **Overview of Cantharidin and Its Uses** [1:47] 3. **Development and Features of Ycanth** [3:16] 4. **Benefits and Availability of Ycanth** [6:22] 5. **Ordering and Billing Process for Ycanth** [9:14] 6. **Conclusion and Additional Resources** [11:01]   Websites Mentioned: https://www.drlisafaast.com/ ----- #### **Becoming a Badass Pharmacy Owner Podcast is a Proud to be Apart of the Pharmacy Podcast Network**

Your Checkup
Compounding Pharmacies vs. FDA-Approved: The Weight Loss Drug Dilemma

Your Checkup

Play Episode Listen Later Mar 31, 2025 29:19 Transcription Available


Send us a message with this link, we would love to hear from you. Standard message rates may apply.The meteoric rise in demand for weight loss drugs has created widespread shortages, leading to the emergence of compounding pharmacies as an alternative source for these medications.• Compounding pharmacies create custom medications by combining, mixing, or altering ingredients to meet specific needs• Unlike FDA-approved medications, compounded drugs don't undergo the same rigorous safety and effectiveness reviews• Dosing errors with compounded weight loss medications have led to serious adverse events requiring hospitalization• Confusion between units, milliliters, and milligrams contributes to potentially dangerous dosing mistakes• Some compounding pharmacies add unproven ingredients like vitamins, L-carnitine, and NAD to their formulations• The long half-life of these medications (about one week) means overdose symptoms can persist for extended periods• Pharmaceutical companies have responded with direct-to-consumer models offering FDA-approved versions at reduced prices• Eli Lilly now offers Zepbound in vial form for approximately $499/month versus $1000+ for pen versions• Novo Nordisk's NovaCare pharmacy provides direct-to-patient delivery of Wegovy single-dose pens at similar price pointsPlease talk to your healthcare provider about what option might be right for you, as these medications require careful consideration and proper dosing is essential for safety.Support the showProduction and Content: Edward Delesky, MD & Nicole Aruffo, RNArtwork: Olivia Pawlowski

GRUFFtalk How to Age Better with Barbara Hannah Grufferman
FDA-Approved Osteoboost: CEO Laura Yecies on Slowing Bone Loss with NASA Tech EP 147

GRUFFtalk How to Age Better with Barbara Hannah Grufferman

Play Episode Listen Later Mar 25, 2025 43:07


RESOURCES & LINKS  - Osteoboost Official Website  - Video: Laura Yecies Discussing Osteoboost  - Bone Health & Osteoporosis Foundation Website  - Email questions to agebetterpodcast@gmail.com   AGE BETTER host Barbara Hannah Grufferman and Laura Yecies, CEO of Osteoboost, discuss Osteoboost, an FDA-approved device using NASA-inspired vibration therapy to combat bone loss. Laura explains how the technology works, its impressive clinical results (85% reduction in spinal bone loss), and who benefits most.     KEY TAKEAWAYS  - Early intervention in bone health is crucial; hip fractures pose significant risks  - Osteoboost uses precision vibration technology inspired by NASA research  - The device works best when combined with nutrition and exercise  - Particularly effective for postmenopausal women with osteopenia  - FDA-approved and backed by clinical studies showing microarchitectural improvements  - Telehealth options are available for prescriptions  - Future studies planned for osteoporosis applications  *Note: For informational purposes only. Consult your healthcare provider before starting any new health regimen.*  Learn more about your ad choices. Visit megaphone.fm/adchoices

Podcast Notes Playlist: Latest Episodes
#179 Paul Saladino - The FDA Approved Poison You Eat Every Day

Podcast Notes Playlist: Latest Episodes

Play Episode Listen Later Mar 9, 2025


Shawn Ryan Show: Read the notes at at podcastnotes.org. Don't forget to subscribe for free to our newsletter, the top 10 ideas of the week, every Monday --------- Paul Saladino, MD, is a double board-certified physician and a prominent advocate for an animal-based diet, known for his controversial views on nutrition and health. He graduated from the University of Arizona College of Medicine and completed his residency at the University of Washington. Saladino is the author of *The Carnivore Code* and *The Carnivore Code Cookbook*, where he argues that many chronic illnesses are linked to poor dietary choices and can be prevented or reversed through proper nutrition. His professional philosophy emphasizes questioning mainstream medical narratives, focusing instead on optimal health through dietary changes. In addition to his writing, Saladino hosts the *Fundamental Health* podcast, where he engages with various experts to discuss health optimization. He co-founded Lineage Provisions, which produces high-quality air-dried meat snacks, and Heart & Soil, offering desiccated organ supplements aimed at enhancing nutrient intake. Recently, he has been involved in projects like a collaboration with Raw Farm USA to create a raw kefir smoothie at Erewhon Market, further promoting his vision of ancestral nutrition and wellness through innovative products. Shawn Ryan Show Sponsors: https://ShawnLikesGold.com | 855-936-GOLD #goldcopartner https://amac.us/srs https://meetfabric.com/shawn https://americanfinancing.net/srs | 866-781-8900 | NMLS 182334, www.nmlsconsumeraccess.org https://hillsdale.edu/srs https://patriotmobile.com/srs | 972-PATRIOT This episode is sponsored by BetterHelp. Give online therapy a try at betterhelp.com/srs and get on your way to being your best self. https://helixsleep.com/srs https://rocketmoney.com/srs https://prizepicks.onelink.me/LME0/SRS https://blackbuffalo.com Paul Saladino Links: Website - https://www.ABNRF.org Instagram - https://www.instagram.com/paulsaladinomd/?hl=en X - https://x.com/paulsaladinomd TikTok - https://www.tiktok.com/@paulsaladinomd2 YouTube - https://www.youtube.com/c/PaulSaladinoMD Heart & Soil - https://heartandsoil.co/ Lineage Provisions - https://lineageprovisions.com/ShawnRyan Learn more about your ad choices. Visit podcastchoices.com/adchoices

Podcast Notes Playlist: Nutrition
#179 Paul Saladino - The FDA Approved Poison You Eat Every Day

Podcast Notes Playlist: Nutrition

Play Episode Listen Later Mar 9, 2025 197:30


Shawn Ryan Show Intro  We are the only species that have forgotten what we are biologically-programmed to eat Metabolic dysfunction, which exists on a continuum, underlies 90% of chronic illness; becoming metabolically healthy through diet and lifestyle change can cure most chronic illnesses Every year, the government sends out $112 billion in food stamps, which serves an average of 42 million people monthly – about 12% of the U.S. populationAbout 70% of this budget is spent on junk food, and about 10% of it – $12 billion – is spent on soda Additives in ultra-processed foods impair our ability to make energy from them; they are poisonous to our metabolism and to the very things that give us life as humans! There is more to the story than calories: The ingredients in these processed foods are poisonous to humans; the quality of the “calories in” impacts the body's ability to do “calories out” Consuming monogastric animals such as pork and chicken is problematic for humans because these animals accumulate polyunsaturated fats, which are harmful to humans; ruminants are better for human consumption In the 1900s, rates of chronic illness were a fraction of what they are today; during this time, about 99% of fat that humans ate were beef tallow, ghee, butter, and lard – there were no seed oils in the human diet! Saturated fats are evolutionary consistent and cardioprotective; consuming excess polyunsaturated fats, like linoleic acid in seed oils, is the true culprit of chronic disease due to their oxidative potential  “If you are insulin sensitive and metabolically healthy, LDL is good for you. It ‘s an immune particle; it's valuable. It's when you become insulin resistant that it becomes a liability because it is part of the causal cascade.”  – Paul Saladino Sugar in fruit is different than processed forms of sugar: There are naturally occurring chemicals in fruit and in honey that mitigate the adverse effects of sugar in the body The solution is simple: We do not need medical breakthroughs to fix our health and cure chronic disease; we just need to return to eating the foods that humans have always eaten Read the full notes @ podcastnotes.orgPaul Saladino, MD, is a double board-certified physician and a prominent advocate for an animal-based diet, known for his controversial views on nutrition and health. He graduated from the University of Arizona College of Medicine and completed his residency at the University of Washington. Saladino is the author of *The Carnivore Code* and *The Carnivore Code Cookbook*, where he argues that many chronic illnesses are linked to poor dietary choices and can be prevented or reversed through proper nutrition. His professional philosophy emphasizes questioning mainstream medical narratives, focusing instead on optimal health through dietary changes. In addition to his writing, Saladino hosts the *Fundamental Health* podcast, where he engages with various experts to discuss health optimization. He co-founded Lineage Provisions, which produces high-quality air-dried meat snacks, and Heart & Soil, offering desiccated organ supplements aimed at enhancing nutrient intake. Recently, he has been involved in projects like a collaboration with Raw Farm USA to create a raw kefir smoothie at Erewhon Market, further promoting his vision of ancestral nutrition and wellness through innovative products. Shawn Ryan Show Sponsors: https://ShawnLikesGold.com | 855-936-GOLD #goldcopartner https://amac.us/srs https://meetfabric.com/shawn https://americanfinancing.net/srs | 866-781-8900 | NMLS 182334, www.nmlsconsumeraccess.org https://hillsdale.edu/srs https://patriotmobile.com/srs | 972-PATRIOT This episode is sponsored by BetterHelp. Give online therapy a try at betterhelp.com/srs and get on your way to being your best self. https://helixsleep.com/srs https://rocketmoney.com/srs https://prizepicks.onelink.me/LME0/SRS https://blackbuffalo.com Paul Saladino Links: Website - https://www.ABNRF.org Instagram - https://www.instagram.com/paulsaladinomd/?hl=en X - https://x.com/paulsaladinomd TikTok - https://www.tiktok.com/@paulsaladinomd2 YouTube - https://www.youtube.com/c/PaulSaladinoMD Heart & Soil - https://heartandsoil.co/ Lineage Provisions - https://lineageprovisions.com/ShawnRyan Learn more about your ad choices. Visit podcastchoices.com/adchoices

Shawn Ryan Show
#179 Paul Saladino - The FDA Approved Poison You Eat Every Day

Shawn Ryan Show

Play Episode Listen Later Mar 5, 2025 197:30


Paul Saladino, MD, is a double board-certified physician and a prominent advocate for an animal-based diet, known for his controversial views on nutrition and health. He graduated from the University of Arizona College of Medicine and completed his residency at the University of Washington. Saladino is the author of *The Carnivore Code* and *The Carnivore Code Cookbook*, where he argues that many chronic illnesses are linked to poor dietary choices and can be prevented or reversed through proper nutrition. His professional philosophy emphasizes questioning mainstream medical narratives, focusing instead on optimal health through dietary changes. In addition to his writing, Saladino hosts the *Fundamental Health* podcast, where he engages with various experts to discuss health optimization. He co-founded Lineage Provisions, which produces high-quality air-dried meat snacks, and Heart & Soil, offering desiccated organ supplements aimed at enhancing nutrient intake. Recently, he has been involved in projects like a collaboration with Raw Farm USA to create a raw kefir smoothie at Erewhon Market, further promoting his vision of ancestral nutrition and wellness through innovative products. Shawn Ryan Show Sponsors: https://ShawnLikesGold.com | 855-936-GOLD #goldcopartner https://amac.us/srs https://meetfabric.com/shawn https://americanfinancing.net/srs | 866-781-8900 | NMLS 182334, www.nmlsconsumeraccess.org https://hillsdale.edu/srs https://patriotmobile.com/srs | 972-PATRIOT This episode is sponsored by BetterHelp. Give online therapy a try at betterhelp.com/srs and get on your way to being your best self. https://helixsleep.com/srs https://rocketmoney.com/srs https://prizepicks.onelink.me/LME0/SRS https://blackbuffalo.com Paul Saladino Links: Website - https://www.ABNRF.org Instagram - https://www.instagram.com/paulsaladinomd/?hl=en X - https://x.com/paulsaladinomd TikTok - https://www.tiktok.com/@paulsaladinomd2 YouTube - https://www.youtube.com/c/PaulSaladinoMD Heart & Soil - https://heartandsoil.co/ Lineage Provisions - https://lineageprovisions.com/ShawnRyan Learn more about your ad choices. Visit podcastchoices.com/adchoices

Pharmacy Podcast Network
Journavx: A Quick Journey into the Novel Non-Opioid Pain Med | Pain Pod

Pharmacy Podcast Network

Play Episode Listen Later Feb 17, 2025 14:32


Extra Extra, Read all about it! Actually, it's a podcast, Listen all about it!  New Pain Med! New Pain Med! New Non-Opioid Pain Med! Suzetrigine (Journavx) is now FDA Approved for Moderate to Severe Acute Pain in Adults, but what fun facts come along with it????? We turn to the Simpsons, Brugada, and enjoy some club seats while succinctly reviewing everything there is to know about this new non-opioid pain medication on the Pain Pod! Come one, come all, to the Pain Pod!!! Pain Guy • www.painguy.us  

Pain Pod
Journavx: A Quick Journey into the Novel Non-Opioid Pain Med | Pain Pod

Pain Pod

Play Episode Listen Later Feb 17, 2025 14:32


Extra Extra, Read all about it! Actually, it's a podcast, Listen all about it!  New Pain Med! New Pain Med! New Non-Opioid Pain Med! Suzetrigine (Journavx) is now FDA Approved for Moderate to Severe Acute Pain in Adults, but what fun facts come along with it????? We turn to the Simpsons, Brugada, and enjoy some club seats while succinctly reviewing everything there is to know about this new non-opioid pain medication on the Pain Pod! Come one, come all, to the Pain Pod!!! Pain Guy • www.painguy.us  

DON'T UNFRIEND ME
Helo & Airline Crash Pt.2, New Pain Drug FDA Approved, Confirmation Highlights & Fake Stories

DON'T UNFRIEND ME

Play Episode Listen Later Feb 1, 2025 158:27


Helo & Airline Crash Pt.2, New Pain Drug FDA Approved, Confirmation Highlights & Fake StoriesJoin Matt, Amy and Olivia tonight at 7pm A-BLOCK: Helo and Airline Crash Pt.2B-BLOCK: New Pain Drug FDA ApprovedC-Block: Best Moments From ConfirmationD-Block: Fake StoriesF-Block: Overtime Random StoriesWatch the Live Show on the following channels: linktapgo.com/thedumshowBecome a supporter of this podcast: https://www.spreaker.com/podcast/the-dum-show--6012883/support.

projectupland.com On The Go
FDA-Approved QuailGuard Treats Cecal Worms And Eyeworms In Wild Bobwhite Quail

projectupland.com On The Go

Play Episode Listen Later Jan 21, 2025 15:14


For bird enthusiasts, hearing about the negative impacts of habitat loss on bobwhite quail isn't anything new. In fact, this issue have been largely blamed for North America's shrinking bobwhite population. However, parasites may have a larger effect on wild quail than previously thought, especially in Texas and Oklahoma. “Something happened,” said Dr. Ron Kendall, the founder of Texas Tech's Wildlife Toxicology Lab. “We saw innumerable quail in the summer of 2010. Conditions were perfect. But by that fall, the quail were gone.” That year, biologists, wildlife managers, researchers, and hunters rallied together and launched "Operation Idiopathic Decline." The operation brought together multiple universities. Scientists explored the potential causes of the quail population crash. “We looked at pesticides, environmental contaminants, viruses, bacteria, and parasites,” said Dr. Kendall. “Lo and behold, we saw these parasitic worms called helminths in the birds.” 

The Rundown
Apple Hit with Rare Sell Rating, J&J's Ketamine-Derived Nasal Spray Gets FDA Approved for Depression

The Rundown

Play Episode Listen Later Jan 21, 2025 8:59


Stock market update for January 21, 2025. Check out our Instagram account @TheRundownDaily

Oncotarget
Pitfalls of FDA-Approved Germline Cancer Predisposition Tests

Oncotarget

Play Episode Listen Later Dec 30, 2024 3:54


BUFFALO, NY - December 30, 2024 – A new #editorial was #published in Oncotarget's Volume 15 on December 24, 2024, titled “Pitfalls and perils from FDA-approved germ-line cancer predisposition tests." Authored by Dr. Wafik S. El-Deiry, Editor-in-Chief of Oncotarget, and Dr. Eli Y. Adashi from Brown University, the article highlights concerns about the risks of a newly approved genetic test for cancer risk. This test, called the “Invitae Common Hereditary Cancers Panel," was approved in 2023 and examines 48 genes linked to inherited cancers, including breast, ovarian, and Lynch syndrome-related cancers. Although the test increases access to genetic information, the authors warn that using it without professional guidance may lead to confusion, stress, and potential harm. One concern is that people can order this test online without consulting healthcare professionals or genetic counselors. Without expert help, users might struggle to understand their results especially if they indicate risks that are unclear or difficult to act on. This can cause unnecessary anxiety and confusion. “The DTC option of germ-line testing for cancer susceptibility should be discouraged given the risks of anxiety, lack of adequate interpretation for variants not strongly associated with cancer, potential for minors to be tested outside the healthcare system and potential for loss of follow-up if test results are not shared with health care professionals or never make it into the medical record.” The editorial also points out ethical and medical issues when minors use these tests. If a child's test is done without medical oversight, results might not be added to their health records, making follow-up care harder to manage and potentially risking their long-term health. Cost is another issue. These tests are often not covered by insurance, which can place a financial burden on families who might need additional testing or medical advice. The researchers emphasize that genetic testing for cancer risk should always include healthcare providers and genetic counseling. This ensures users fully understand their results and receive proper guidance. The authors also call on the US Food and Drug Administration (FDA) to provide clear rules for using these tests, particularly for minors. In conclusion, while genetic testing holds great potential for improving cancer prevention and care, its benefits must not come at the cost of safety and public health. Responsible use of these tests will require collaboration between regulators, healthcare professionals, and testing companies to address the risks and ensure these tools are used effectively. DOI - https://doi.org/10.18632/oncotarget.28677 Correspondence to - Wafik S. El-Deiry - wafik@brown.edu Video short - https://www.youtube.com/watch?v=DjKpiBNDWHo Subscribe for free publication alerts from Oncotarget - https://www.oncotarget.com/subscribe/ About Oncotarget Oncotarget (a primarily oncology-focused, peer-reviewed, open access journal) aims to maximize research impact through insightful peer-review; eliminate borders between specialties by linking different fields of oncology, cancer research and biomedical sciences; and foster application of basic and clinical science. Oncotarget is indexed and archived by PubMed/Medline, PubMed Central, Scopus, EMBASE, META (Chan Zuckerberg Initiative) (2018-2022), and Dimensions (Digital Science). To learn more about Oncotarget, please visit https://www.oncotarget.com and connect with us: Facebook - https://www.facebook.com/Oncotarget/ X - https://twitter.com/oncotarget Instagram - https://www.instagram.com/oncotargetjrnl/ YouTube - https://www.youtube.com/@OncotargetJournal LinkedIn - https://www.linkedin.com/company/oncotarget Pinterest - https://www.pinterest.com/oncotarget/ Reddit - https://www.reddit.com/user/Oncotarget/ Spotify - https://open.spotify.com/show/0gRwT6BqYWJzxzmjPJwtVh MEDIA@IMPACTJOURNALS.COM

Tiny Matters
Frostbite: From Napoleonic era treatments to the first FDA approved frostbite drug

Tiny Matters

Play Episode Listen Later Dec 11, 2024 27:26 Transcription Available


Dominique Jean Larrey lived quite a life. He was born in 1766, and at the age of 13, had to walk from his home in a French village to study in the city of Toulouse. That journey was 70 miles, and yes, he walked it. That would be important much later in his life, when he found himself walking through the bitter cold in Russia as the Chief Surgeon of Napoleon's army. During that time, Napoleon's troops had to contend with the reality of Russian cold and temperatures that got as low as -37 degrees Celsius, which is about -35 Fahrenheit.Larrey attributed his ability to withstand the cold to his walking. But many of the soldiers around him wound up with frostbite, and to treat them, Larrey suggested slowly rewarming the affected area and rubbing it with snow. Frostbite treatment has been on quite the journey since then, and it was just earlier this year that the FDA approved the first drug to treat frostbite in the US, which is exciting news for the doctors who see cases of frostbite and for patients who are often left with the horrific reality of amputation. Send us your science stories/factoids/news for a chance to be featured on an upcoming Tiny Show and Tell Us bonus episode and to be entered to win a Tiny Matters coffee mug! And, while you're at it, subscribe to our newsletter at bit.ly/tinymattersnewsletter.Links to the Tiny Show & Tell story are here and here. All Tiny Matters transcripts and references are available here.

Never Show the Monster
86. Horror of 2024 - The Substance: Is That FDA Approved?

Never Show the Monster

Play Episode Listen Later Dec 11, 2024 89:40


Hey how are you doing today? Do you feel good? Are you feeling good about yourself? If not, have I got the product for you - a lil substance you can inject to spawn a hotter version of yourself who will ruin your life. Are you interested?  We're talking THE SUBSTANCE (2024), a very weird and disgusting and delightful film we can not recommend highly enough. Don't cheat yourself out of watching this without spoilers! And ladies, remember - you're more than just one b00b Follow us on Bluesky: https://bsky.app/profile/noshowmonster.bsky.social Follow us on Instagram: https://www.instagram.com/noshowmonster/ Email us at noshowmonster@gmail.com Follow Kelly Attaway Bluesky: https://bsky.app/profile/kellyattaway.bsky.social Instagram: https://www.instagram.com/spooky_kellyyy/ Follow Chelsea Hollander lol SIKE you can't she's not online because she values her mental health and wellbeing  Hosted by Kelly Attaway and Chelsea Hollander Produced by Kelly Attaway Art by Ryan Tate Theme by Unicorn Heads    

Moving Medicine
What to know about FDA-approved cannabis-derived products

Moving Medicine

Play Episode Listen Later Dec 5, 2024 9:34


The U.S. Food and Drug Administration has approved cannabis-derived medications for several indications. In this episode, family practitioner Randy Easterling, MD, highlights the current regulatory status of FDA-approved cannabis-derived medications and their approved uses.     ⭐⭐⭐⭐⭐

The Sleep Is A Skill Podcast
183: Kate Willis, Speaker & VP of Commercialization at Neurovalens: The New Prescription FDA-Cleared Sleep Aid Device That Aims To Transform Insomnia & Jet Lag!

The Sleep Is A Skill Podcast

Play Episode Listen Later Nov 22, 2024 43:33


Kate Willis is an esteemed leader in Healthcare and MedTech, known for her strategic prowess and innovative approaches. Currently, she serves as the Vice President of Commercialization at Neurovalens, responsible for leading all global and US commercial functions, including the US launch. Her career highlights include serving as the Director of Government Affairs and Advocacy, where she has been a powerful force in shaping industry standards and policies.Kate's robust track record of leadership extends through premier companies such as Nevro, Medtronic, Nuvasive, and Zimmer Biomet, where her initiatives have not only spurred organizational growth but have also earned her multiple accolades. These honors include prestigious recognitions such as multiple President's Club awards, Sales Rep of the Year, and Rookie of the Year. Beyond her healthcare expertise, Kate is a recognized figure in the arts as a producer and investor, with successful ventures in Broadway, West End, and film productions. Her unique flair for bridging the realms of business and entertainment underlines her diverse capabilities and visionary outlook. SHOWNOTES:

Lyme Time with Ali from TheTickChicks.com
EP 76: NEW FDA-Approved Lyme test and the latest at Lyme Biobank/Bay Area Lyme Foundation research with Liz Horn, PhD, MBI

Lyme Time with Ali from TheTickChicks.com

Play Episode Listen Later Oct 24, 2024 53:30


Inside the Lab
Newly FDA Approved Alzheimer's Biomarkers Testing: How to Implement Such Tests in Core Laboratory?

Inside the Lab

Play Episode Listen Later Oct 21, 2024 35:34


The diagnostic paradigm for Alzheimer's disease (AD) has rapidly shifted in the last five years as fluid-based biomarker testing has emerged as a reliable, accurate, and accessible means to detect amyloid pathology when evaluating a patient for cognitive decline. This podcast is designed to help pathologists and laboratory professionals gain an understanding of plasma testing for markers such as Abeta40/42, P-tau181, and P-tau217 which are rapidly appearing in the commercial space and how healthcare providers have begun incorporating these tests into routine neurology practice. This podcast will help participants to understand the advantages and limitations of these assays as well as their potential application when a physician is evaluating a patient for AD. 

The Sydney Hollis Show
FDA Approved Drive-Through Tranquility - Ep 210

The Sydney Hollis Show

Play Episode Listen Later Oct 18, 2024


Rexulti. Power of Attorney for NIL. Podcasting, for who?

Future Ear Radio
132 - Ross O'Neill, PhD & Hubert Lim, PhD - Lenire: The First FDA-Approved Bimodal Tinnitus Treatment

Future Ear Radio

Play Episode Listen Later Oct 11, 2024 53:22


Guests: Ross O'Neill Ph.D (Founding CEO) & Hubert Lim Ph.D (Chief Scientific Officer) of Neuromod Dave is joined by Ross & Hubert to discuss: - The backstory of how Ross & Hubert met and ultimately partnered together on Lenire - Hubert's research and papers he wrote about paired stimulation & Pavlovian conditioning, which included data that identified tongue stimulation combined with sound as a promising direction to pursue - An overview of what exactly tinnitus is and why Lenire presents such a novel approach to treating tinnitus - Other types of synchronous-stimuli approaches that have emerged in other healthcare verticals (i.e. mirror therapy for phantom limb pain) - The challenging process of gaining FDA approval and the clinical trials that were conducted throughout the process - Being featured as the cover story on Nature Communications - The initial roll-out of Lenire, the current state of the provider network, and the real-world data that's being collected and published

Healing The Source
"It's FDA-Approved & My Doctor Recommended It, So It Must Be Healthy & Safe" -- wrong!

Healing The Source

Play Episode Listen Later Oct 7, 2024 14:42


I dive deep into the illusion of safety behind FDA approvals and doctor recommendations. I unpack the shocking reality that the FDA, the very agency tasked with protecting public health, is often funded by the same conglomerates it's supposed to regulate. From fast-tracked pharmaceuticals to harmful food additives like aspartame and glyphosate, I reveal how corporate interests and profit often overshadow genuine concern for our well-being. Exploring conflicts of interest embedded within the system, like the opioid crisis, I challenge the notion that “doctor-recommended” always means safe. I urge you to become your own health advocate, question the system, and reconnect with nature to truly reclaim your health. This episode is a must-listen for anyone ready to break free from blind trust in labels and take control of their wellness journey. Resources:  Puori Supplements discount code: HEALINGTHESOURCE for 20% off your order sitewide (don't miss out PW1 grass-fed protein powder and CP1 collagen!!) Follow the host, Claudia Gilani, here, and check out HealingTheSource.org

SleepTech Talk
Episode 82- New Product Alert! New FDA Approved Portable Sleep Study Unit

SleepTech Talk

Play Episode Listen Later Aug 26, 2024 32:04


Let's meet Cathy Goldstein, MD as she talks to SleepTech Talk about some exciting new technology in portable sleep studies. Dr Goldstein was the principle investigator (PI) for validation study Huxley Medical's latest FDA approved portable PSG unit, Sansa. She talks to us about why it's different and how it will help even more patients. Dr Cathy Goldstein is a Professor of Neurology at University of Michigan. She is also an internationally recognized expert in sleep tracking and sleep tracking technology. Dr Goldstein serves as a senior editor of Principles and Practices of Sleep Medicine and holds editorial roles for the Journal of Clinical Sleep Medicine. Listen in as we talk to Dr Goldstein and dive into her wealth of knowledge. A huge thanks to our sponsors: Medbridge Healthcare: For Job Opportunities with MedBridge Healthcare click here: https://medbridgehealthcare.com/careers/ Don't forget to Like, Share, Comment, and Subscribe! Learn more about the show at https://www.sleeptechtalk.com/thetechroom Credits: Audio/ Video: Diego R Mann; Music: Pierce G Mann Hosts: J. Emerson Kerr, Robert Miller, Gerald George Mannikarote Copyright: ⓒ 2024 SleepTech Talk Productions Sleep apnea, OSA, obstructive sleep apnea, dental appliance, oral appliance, oral sleep appliance, inspire, surgery, sleep surgery, CPAP

NutritionFacts.org Video Podcast
Is FDA-Approved Bioidentical Hormone Replacement Therapy Safe?

NutritionFacts.org Video Podcast

Play Episode Listen Later Aug 19, 2024 4:43


As of 2019, there are urine-free FDA-approved bioidentical hormones that skirt the standardization concerns of compounded preparations. Are they any safer?

America Dissected with Abdul El-Sayed
Scientists Argue that this Genetic Test's Results are “no better than a coin flip.” The FDA approved it anyway.

America Dissected with Abdul El-Sayed

Play Episode Listen Later Jul 16, 2024 51:56


Recently, the FDA approved a genetic test for opioid use disorder despite clear opposition from scientists and the FDA advisory panel that had reviewed the evidence. The case demonstrates the space where Pharma's incentive may drive innovation that may not help–or worse, cause harm. Abdul reflects on how genetic essentialism and the wrong incentives can reinforce each other. Than he speaks with Dr. Elizabeth Joniak-Grant, a sociologist and patient advocate who voted against the genetic test. This show would not be possible without the generous support of our sponsors. America Dissected invites you to check them out. This episode was brought to you by: Marguerite Casey Foundation invites you to sign up for their new Summer School program at caseygrants.org/summerschool. Henson Shaving invites you to find the razor that will last you a lifetime. Go to https://hensonshaving.com and enter AD at checkout to get 100 free blades with your purchase. (Note: you must add both the 100-blade pack and the razor for the discount to apply.) Blueland invites you to celebrate Plastic Free July with up to 25% off your Blueland order. Go to Blueland.com/america now for your special limited time offer.

Science Friday
The FDA Approved The First CRISPR-Based Therapy. What's Next?

Science Friday

Play Episode Listen Later Feb 7, 2024 18:00


Last month the FDA approved a new treatment for sickle cell disease, the first medical therapy to use CRISPR gene editing technology. It works by identifying the gene or genes causing the disorder, modifying those genes and then returning them to the patient's body.There are now two gene therapies offered by pharmaceutical companies for sickle cell disease: Casgevy from Vertex Pharmaceuticals and CRISPR Therapeutics, and Lyfgenia from BlueBird Bio. But prices for these one-time treatments are steep: Casgevy costs $2.2 million per patient and Lyfgenia $3.1 million.Both promise a full cure, which would be life-changing for patients with this debilitating condition. Over 100,000 Americans, mostly of African descent, have sickle cell disease.This milestone raises more questions: What will be the next disease that CRISPR can help cure? And is it possible to reduce the costs of gene therapy treatments?Ira talks with Dr. Fyodor Urnov, professor of molecular and cell biology and scientific director of technology and translation at the Innovative Genomics Institute, based at the University of California, Berkeley, about the future of CRISPR-based cures.Transcripts for this segment will be available the week after the show airs on sciencefriday.com. To stay updated on all things science, sign up for Science Friday's newsletters.