MPR Weekly Dose

Glenmark to launch the first generic version of Flovent HFA, expanding affordable access; achondroplasia treatment granted accelerated approval; Dupixent approved for allergic fungal rhinosinusitis; and a swallowable balloon offers a unique outpatient alternative for weight management.

We explore the FDA's expansion of Wakix as the first non-scheduled treatment for pediatric cataplexy; a Taltz and Zepbound combo shows promise in skin clearance for patients with psoriasis and obesity; we also look at the frontier of mental health with synthetic psilocybin; there's phase 3 results from a potential new treatment for chronic inducible hives; and a long-acting HIV injection could be...

Recent medical updates highlight the long-term health benefits of the universal hepatitis B birth dose, alongside FDA milestones including the approval of Optune Pax for pancreatic cancer and a pembrolizumab-based regimen for platinum-resistant ovarian cancer, and the granting of priority review to oveporexton for narcolepsy type 1.

Combo treatment aims to be latest to enter the weight loss space; Amgen refuses to remove drug from market despite FDA request; Novo Nordisk threatens legal action against Hims & Hers; an oral film formulation of sildenafil is approved; and the FDA accepts the NDA for zanzalintinib plus atezolizumab for metastatic colorectal cancer.

AAP maintains routine vaccine recs despite CDC changes; FDA warns of serious injury with wound and burn products; subcutaneous Alzheimer disease treatment under review; Cardamyst nasal spray available; and the FDA places clinical hold on 2 gene therapies.

New research on acetaminophen use during pregnancy; the chikungunya vaccine Ixchiq is withdrawn; FDA approves Nexplanon for up to 5 years of use; suicidal ideation warning removed from GLP-1s; at-home neuromodulation therapy cleared for adults with major depressive disorder.

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.