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
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.