MPR Weekly Dose

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.

Seizure medication recalled due to wrong strength on carton; Gene therapy gains Fast Track status for Parkinson disease; Dendritic cell vaccine being developed for pancreatic cancer; Generic version of sickle cell disease treatment Endari is made available

New steroid-free topical for atopic dermatitis; A refillable ocular implant for the treatment of  neovascular (wet) age-related macular degeneration returns following recall; A neuroimmune modulation device shows clinical benefit in adults with rheumatoid arthritis; FDA denies Novo Nordisk's once-weekly insulin icodec; And a smarthphone therapy shows benefit for patients with fibromyalgia.

New maintenance treatment approved for COPD; Authorized generic version of Victoza launches; Duchenne muscular dystrophy treatment indication expanded; Narcolepsy treatment expanded for certain pediatric patients; FDA clears digital therapeutic for ADHD.  

Skyrizi has been approved for ulcerative colitis; New pneumococcal vaccine approved; An indictment may impact as much as 50,000 patients who need ADHD meds; Results announced for Moderna's next-gen COVID-19 vaccine; Farxiga approval expanded.

Two glucose monitoring systems have been cleared for over-the-counter sale; Arexvy gains approval for adults aged 50 to 59 years; Kevzara approved for active polyarticular juvenile idiopathic arthritis; Generic Duchenne muscular dystrophy drug is made available; and Iqirvo gets accelerated approval for primary biliary cholangitis.

First generics of heart failure drug gain approval; mRNA vaccine approved for RSV; CDC make drug recommendation for STI prevention; Advisory Committee vote on MDMA for PTSD; Rinvoq approval expanded

Extended-release ADHD treatment gains approval; An interchangeable biosimilar to Soliris is approved; Investigational treatment shows promise for improving depression and insomnia; The FDA vote on a blood-based colorectal cancer diagnostic; Survey reveals public attitudes towards the FDA.

Self-administered device cleared to treat stress urinary incontinence in women; Autoinjector warning for relapsing MS treatment; COVID-19 preexposure prophylaxis investigational treatment looks promising; Biosimilars for Eylea approved; Imdelltra approved for extensive stage small cell lung cancer with disease progression.  

Reliability of COVID-19 tests unreliable; Insulin pump app updated following battery issue; Noninvasive colorectal cancer test gets FDA approval; Self-collection HPV screening option; National Drug Threat Assessment highlights illicit drugs currently endangering the US. 

Dr. Michael Ganio, ASHP's Director of Pharmacy Practice and Quality, joins me to discuss the current drug shortage crisis, which has reached new levels.

Dr Charles Raison, the Director of Clinical Research at the Usona Institute and Professor in the Department of Psychiatry at the University of Wisconsin–Madison, joins me to discuss the potential of psilocybin as a therapy for major depressive disorder.

Asthma treatment gains approval for severe cases in pediatrics; Dovato gains expanded indication; Decision taken to remove ALS drug from market; Complete Response Letter issued for apomorphine device; At-home Mpox test kit made available.

First prescription smartphone app approved for major depressive disorder; Novel blood test to detect TBI; Zevtera approved for bloodstream infections; Mpox vaccine is now commercially available; Algorithm cleared for LVEF dectection.  

Preexposure prophylaxis approved for COVID-19; Nexletol and Nexlizet gain expanded approval; Novel Duchenne muscular dystrophy treatment; First blood test to screen for malaria in donors; Warning letter for OTC topical analgesic products.  

Nasal spray approved for chronic rhinosinusitis; Endothelin receptor antagonist gains approval to lower blood pressure in hypertension; One-time stem cell treatment approved for metachromatic leukodystrophy; NASH treatment gains accelerated approval; New automated insulin delivery system for type 1 diabetes.  

Weight loss treatment has approval expanded; Paxlovid with Emergency Use Authorized label must be disposed of; psychedelic gets Breakthrough therapy designation; Advisory Committee announce meeting to discuss Alzheimer treatment; ALS treatment trial results

Over-the-counter birth control pill to be available in the coming weeks; first over-the-counter continuous glucose monitor to be available starting this summer; the 2024-2025 US influenza season vaccine will be trivalent; LSD granted Breakthrough Therapy for treatment of generalized anxiety disorder; interchangeable biosimilars to Prolia and Xgeva approved. 

FDA withdraw multiple myeloma treatment after a confirmatory trial showed an increased risk of death; latest efficacy results for lower respiratory tract disease vaccine; CDC Chikungunya virus vaccine recommendations; Complete Response Letter issued to investigative schizophrenia treatment; new treatment for complicated UTIs including pyelonephritis; over-the-counter eye ointments recalled.  

First treatment approved to reduce allergic reactions in those with multiple food allergies; T-cell therapy given accelerated approval to treat unresectable or metastatic melanoma; Vit D supplement recalled due to superpotency; cannabidiol may help resolve the symptoms of pericarditis; FDA warn against certain wearables that claim to measure blood glucose.

FDA approves first treatment for severe frostbite; Eohilia gains approval to treat eosinophilic esophagitis; MDMA accepted for Priority Review for PTSD; novel subcutaneous to be reviewed for prurigo nodularis, atopic dermatitis; OTC pulse oximeter device is cleared.

Combination intravenous formulation of acetaminophen and ibuprofen approved; recommendations from the ADA for dealing with acute dental pain; RSV vaccine under review for younger adult age group; Gilead call halt on investigational leukemia treatment hagrolimab; athlete foot spray recalled.

Biogen discontinue Alzheimer treatment; The American Academy of Dermatology issue new acne vulgaris management guidelines; Update for ongoing availability of Paxlovid; Narcolepsy/ADHD treatment recalled for containing wrong drug; FDA warn against copycat eye drop products

T-cell malignancies prompt label changes for certain T-cell immunotherapies; Novel opioid provides in-built protection against overdose; Hypocalcemia risk with Prolia; At-Home semen insemination kit cleared; New asthma rescued medicine approved