MPR Weekly Dose

Fifty-eight health experts have weighed in on the future of wellness. In this episode, we sit down with Annika Urban, health editor for US News and World Report, to analyze the implications of these findings. Annika shares her perspective on the major shifts happening across the health spectrum.

ACIP votes to change hep B vaccination for infants; positive results for retatrutide; Omisirge approved; counterfeit Ozempic seized by FDA; gene therapy approved for Wiskott-Aldrich syndrome.

Jaypirca gains expanded approval; allograft approved to restore peripheral nerve function; baxdrostat to be reviewed as an add-on treatment for hypertension; treatment for a genetic eye disorder that causes vision loss shows promise; and an autoinjector to treat edema is accepted for Priority Review.

Tonmya now available for fibromyalgia; safety warnings for DMD treatment; mitapivat shows mixed results in sickle cell disease trial; Redemplo approved for familial chylomicronemia syndrome; Hyrnuo approved for HER2-mutant NSCLC.

The FDA requests boxed warnings be removed from HRT product labels; Caplyta approved for MDD; Darzalex Faspro gains new indication; investigational MS treatment looks promising; trial investigates simplified HIV regimen.

FDA restrict the sale of unapproved fluoride products; the AAP statement on leucovorin in ASD; at-home prenatal ultrasound; Kygevvi approved; Gazyva reduces SLE disease activity.

Label changes for tranexamic acid; new approval for Tezspire; psychedelic gains Breakthrough Tx for depression; oral semaglutide approved to reduce MACE risk in T2DM; Gazyva approved for lupus.

New treatment approved for Bipolar I disorder; IBD treatments gain expanded approval; blood-based test for early detection of Alzheimer disease; and an oral glucagon-like peptide-1 treatment continues to show promise.  

CDC approves new immunization schedule; new treatments approved for edema, idiopathic pulmonary fibrosis, and high risk cutaneous squamous cell carcinoma; and the FDA grants Breakthrough therapy designation to a novel influenza therapy.

New treatment approved for primary humoral immunodeficiency; eyedrops now available to improve near vision; Tremfya approval expanded to include pediatric plaque psoriasis, psoriatic arthritis; FDA fast tracks treatments for methamphetamine intoxication, Alzheimer disease.

The CDC recommends changes to MMRV vaccine use; Trump administration claims acetaminophen linked to autism; first Barth syndrome treatment gets green light; gene therapy looks promising for Huntington disease; and a new SC formulation of Keytruda gains approval.

New device approved to prevent intrauterine adhesions; oral GLP-1 receptor agonists assessed in head to head trial; nasal spray formulation of bumetanide gains approval; Capvaxive elicits immune response in children aged 2 to 17 years; and a primary biliary cholangitis treatment is withdrawn from the market.

COVID-19 vaccine approvals; CDC leadership in turmoil; orforglipron weight loss trial results; Ixchiq license suspended by FDA; REMS updated for Filspari

COVID-19 vaccine approvals; CDC leadership in turmoil; orforglipron weight loss trial results; Ixchiq license suspended by FDA; REMS updated for Filspari

The American Academy of Pediatrics release their own immunization schedule; The American Heart Association update 2017 guidelines for the prevention of high blood pressure; weight loss drug gains indication to treat noncirrhotic MASH; FDA approve a new fibromyalgia treatment; investigational SCD Tx to meet trial endpoint.

Nerve stimulation device cleared for sleep apnea; Skysona safety update; new non-cystic fibrosis bronchiectasis treatment; FDA cracks down on animal-derived thyroid meds; RSV therapy to be discontinued.

Class-wide label change for opioids; positive results for oral GLP-1; migraine prevention therapy approved for children; FDA removes restriction on Ixchiq for older adults; Modeyso approved for rare brain tumor.

Empaveli approved to treat two rare kidney diseases; Elevidys available again for ambulatory patients; Mounjaro shows benefit in cardiovascular disease; wearable cardiac monitor gets clearance; upadacitinib trial shows hair regrowth in individuals with alopecia areata.

Elevidys shipments paused following third death; FDA committee votes against brexpiprazole combo for PTSD; Rapiblyk now available for SVT; sleep apnea pill looks promising; JUUL e-cigarettes gain marketing authorization.

New indication for Kerendia; investigational therapy shows promise for hypertension; Novolog interchangeable biosimilar gets approval; trial results for hormone-free contraceptive; Shingrix now supplied in a prefilled syringe.

Lawsuit filed against RFK Jr over vaccine policy changes; oral on-demand treatment approved for HAE; OTC cuffless blood pressure monitor gets greenlit; dosing schedule update for Alzheimer treatment; REMS requirement removed for endothelin receptor antagonist meds.

Wristband that provides relief for upper limb tremor is approved; FDA warns of clinically significant weight loss in younger kids taking ADHD meds; REMS removed for CAR T-cell immunotherapies; treatment approved for lung cancer patients with EGFR exon20 insertion mutations; and CDC committee recommends removing preservative from flu vaccines.

Novo Nordisk end their partnership with Hims & Hers; update to Vizamyl labeling; autoinjector approved for pediatrics with lupus nephritis; psilocybin shows promise in treatment-resistant depression; sotatercept phase 3 trial results.

Nucala gains new indication; the FDA are set to require placebo-controlled trials to evaluate COVID-19 vaccines; pruritus reported following discontinuation of antihistamines; oral carbapenem antibiotic looks promising for cUTIs; investigational celiac disease Tx gets Fast Tracked

At-home cervical cancer screening device gains clearance; the FDA indicates it wants to remove pediatric fluoride products from the market; the chikungunya vaccine is put on-pause for some individuals; a subcutaneous autoinjector is approved to treat migraines; and the FDA will review a gene therapy for Hunter syndrome.

A new epinephrine nasal spray dosage has been approved for pediatrics; FDA agree to review Semaglutide for weight management; A wearable defibrillator is cleared to prevent sudden cardiac arrest; a low dose formulation of chlorthalidone is approved to treat hypertension; and Selarsdi is now interchangeable with Stelara.

Rinvoq approved for giant cell arteritis; telehealth companies collaborate with Novo Nordisk for Wegovy access; epidermolysis bullosa wound healing treatment approved; Imaavy approved for gMG; New nasal powder approved for migraine treatment.

The FDA issues alert regarding a compounded topical finasteride; plant-based alkaloid shows improvement for smoking cessations; potential new treatment option for GERD; and the CDC's Advisory Committee on Immunization Practices make new recommendations.

Pfizer ends danuglipron clinical program for obesity; FDA warns about counterfeit Ozempic; daily pill shows promise in reducing HbA1c; mavacamten misses in nonobstructive HCM trial and the FDA clears smart belt device reduce fall injury.

Uplizna gains new indication; Vanrafia approved for proteinuria in IgAN; Erzofri now available for schizophrenia; setmelanotide shows promise in hypothalamic obesity; GLP-1RAs may reduce dementia risk.  

New treatments for Prader-Willi Syndrome and hemophilia; FDA fast tracks a chlamydia vaccine candidate; over-the-counter test cleared for identifying chlamydia, gonorrhea and trichomoniasis; semaglutide improves walking ability in patients with peripheral artery disease; and Imfinzi combo therapy approved for MIBC.    

New antibiotic has been approved for uncomplicated UTIs; Cabometyx approved for advanced neuroendocrine tumors; new rosacea treatment option; Tremfya gains Crohn disease indication; Department of HHS cuts 10,000 jobs. 

Influenza vaccine recommendations made for upcoming season; a patient dies following Elevidys infusion; Chikungunya vaccine now available and recommended for those traveling to areas with an outbreak; novel Alzheimer disease treatment launches; risk evaluation and mitigation strategies removed for hypertension treatment.

First Xolair biosimilar approved, Wearable furosemide loop diuretic gains expanded indication; Implant approved for macular telangiectasia; Novel treatment shows promise in hypertension; And testing reveals high benzene levels in over-the-counter acne treatments.

Labeling changes for testosterone products; food allergy treatments compared; FDA approves stroke Tx; COVID-19, flu vaccine effectiveness for recent season; Neffy 1mg approved

REMS requirement removed for schizophrenia treatment; new copper intrauterine device approved; Wegovy, Ozempic no longer in short supply; stem cell therapy for chronic lumbar disc disease fast tracked; ecopipam shows promise for Tourette syndrome.

New vaccines to protect against meningococcal disease and chikungunya virus; skin prep product recalled due to fungal contamination; rapid-acting insulin biosimilar approved; and twice-yearly lenacapavir gets FDA's priority review for HIV PrEP.

Study identifies potential treatment strategy for high-threshold peanut allergy; Emblaveo approved for complicated intra-abdominal infections; new tablet formulation of Evrysdi; FDA fast tracks investigational agents for Alzheimer disease and cannabis use disorder.  

FDA say there are reports that diabetes patients are missing critical safety data from their smartphone devices; A wearable continuous apomorphine infusion device has been approved for Parkinson disease ‘off' periods; New migraine and pain treatments get the green light; And a study suggest propranolol may cut stroke risk in certain patients.  

Ozempic gains expanded approval; MS treatment gets Boxed Warning added to label; Monotherapy approval granted for treatment resistant depression Tx Spravato; Leqembi gains  maintenance regimen; Enhertu gains new Breast CA indication.  

The FDA has issued a proposal to remove a common decongestant in over the counter products; A follow-up study assesses the efficacy of a schizophrenia treatment; The FDA's Endocrinologic and Metabolic Drugs Advisory Committee panel takes vote on the potential of approving a new diabetes treatment; IV ibuprofen adverse reactions examined; And semaglutide found to improve liver fibrosis.  

Libby Baney, Senior Advisor to ASOP Global and a partner at Faegre Drinker Consulting, talks to MPR about the current state of online pharmacies and what is being done to protect patients. 

Supplies of a significant number of IV solutions have been impacted by Hurricane Helene; First at-home COVID-19/Flu over-the-counter antigen test gains market authorization; DOJ clamp down on fake online pharmacies; Investigational therapy Fast Tracked for treatment resistant depression; and Cologuard Plus gets cleared for colorectal cancer screening. 

The FDA clears capsule that creates sensation of fullness in the stomach; Complete Response Letter issued for gastroparesis treatment; Apple's sleep apnea notification feature gets clearance; Keytruda gains malignant pleural mesothelioma indication; Ebglyss approved for atopic dermatitis

New drug approved to treat ulcerative colitis; Once-weekly insulin efsitora investigated in type 1 diabetes; Dupilumab shows efficacy for treating urticaria; A twice-yearly injection shows potential for treating severe asthma; and GSK calls an end to their development of a herpes vaccine.

CDC Advisory Committee issue vaccine guidelines for flu season; Smallpox vaccine gains expanded indication; Updated Novavax COVID-19 vaccine; Over-the-counter gel for erectile dysfunction; New inserter system for placement of contraceptive intrauterine system.

Genentech decide to remove Fuzeon from US market; Rybrevant and Lazcluze approved as first-line treatment for certain patients with EGFR-mutated advanced NSCLC; FDA warning regarding unapproved potassium phosphates; Otezla approval expanded to include treatment of pediatric patients; Results from tirzepatide diabetes risk reduction study.

New Treatment for Primary Biliary Cholangitis; Nemluvio approved for prurigo nodularis; FDA Denies MDMA for PTSD; New hypoparathyroidism treatment; First digital therapeutic approved for depression.

The FDA give an updated on the availability of obesity drugs; The CDC has issued an updated guideline on contraceptive use; The first T-cell gene therapy is approved for synovial sarcoma; Lymphir gains approval for relapsed or refractory cutaneous T-cell lymphoma; Fabhalta gains a new indication.

FDA voice concerns over compounded semaglutide; New treatment approved for mild to moderate dementia of the Alzheimer type; Colorectal cancer screening test gets green light; Leqselvi approved for alopecia; And peanut allergy treatment gains expanded indication.

Duchenne muscular dystrophy treatment now available; Noise therapy wearable for nasal congestion; Treatment for delaying diabetes gets Fast Tracked; Soliris biosimilar approved; And the first orally-disintegrating contraceptive.