Pfizer-BioNTech bivalent vaccine under investigation; Trial evaluating HIV prevention vaccine discontinued; Early detection sepsis test cleared; Trial results for RSV-associated disease vaccine; Combo Tx for HCC recurrence shows promise.
MPR Weekly Dose Podcast
FDA grant accelerated approval to Alzheimer disease treatment; New fixed-dose asthma treatment; NERD therapy looks promising; Leukemia drug to be withdrawn in 2023; Pertussis prevention treatment approved for use during pregnancy.
Risk evaluation and mitigation strategy updated for abortion pill, mifepristone; Potential PTSD therapy shows positive results; A host of HIV meds are to be discontinued in the next year; Weight-loss treatment gains expanded approval in pediatrics; Experts rank their best diets for a variety of categories.
Interim guidance for influenza treatment with limited oseltamivir; FDA panel take vote on omecamtiv mecarbil; Tecentriq gains new indication; Potential combo COVID-19 and influenza vaccine; Detect COVID-19 tests recalled.
New authorization for COVID-19 vaccines in certain children; Narcan nasal spray to be reviewed for OTC status; Empagliflozin assessed in children with diabetes; a major depressive disorder therapy gains fast track status; and Tecentriq has an indication withdrawn.
FDA pulls bebtelovimab EUA; compounding guidance issued in light of the amoxicillin shortage; the first fecal microbiota treatment is approved; a treatment for Alzheimer disease agitation shows promise; and a gene therapy for Duchenne muscular dystrophy is accepted for Priority Review.
Newly approved gynecologic cancer treatment; Zejula use restricted; intrauterine system use extended; a second insulin product is approved as a biosimilar to Lantus; and an FDA Advisory Committee take a vote on tenapanor.
USPSTF recommendations on estrogen and progesterone; semaglutide assessed in obese teenagers; efficacy and safety data released for investigational maternal RSV vaccine; updates to Clozapine REMS; FDA panel votes on investigational CNS/leptomeningeal metastasis treatment.
Approvals for relapsed or refractory multiple myeloma, non-radiographic axial spondyloarthritis, and unresectable hepatocellular carcinoma; advisory committee takes vote on potential treatment for anemia of chronic kidney disease; and an oral formulation of pulmonary arterial hypertension treatment.
FDA Panel votes on the potential removal from the market of Makena; results from an apixaban trial of patients with atrial fibrillation and valvular heart disease; reports of serious ocular complications with monkeypox infection; the novavax vaccine becomes the latest authorized COVID-19 booster; and treatments for nephropathy and ALS have their review period extended.
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