Two diabetes drugs permanently discontinued; Consistent reduction in schizophrenia symptoms found with an investigational Tx; Positive results for investigational social anxiety disorder therapy; High-concentration Humira biosimilar approved; Sleep apnea treatment expanded for pediatrics with Down syndrome.
Limits on acetaminophen levels in combination opioid products linked to declines in liver injuries; Investigational Alzheimer disease drug fails to show efficacy; Bempedoic acid assessed for reducing major adverse cardiovascular events; Commercial blood test for suspected TBIs; Mammography regulations updated.
Kevzara approved for polymyalgia rheumatica; Skyclarys approved for Friedreich ataxia; Emergency authorization granted to at-home COVID-19, flu test; Drug-resistant bacteria virus spiking in the US; FDA clamps down on unlawful xylazine imports.
Results from COVID-19 postexposure prophylaxis study of molnupiravir; Treatment approved to reduce proteinuria in adults with primary immunoglobulin A nephropathy; Intravitreal injection approved for geographic atrophy secondary to AMD; Potential vaccines for melanoma and pregnant individuals to help protect against RSV complications in infants.
FDA Committee take vote on possible OTC Narcan; Rebyota available to prevent CDI recurrence; Risk of maternal sepsis lowered with azithromycin; Cinbinqo indication expanded; Topical treatment shows promise for hand eczema.
Type 2 diabetes treatment discontinued; Depression, postpartum treatment gets Priority Review; Hypothyroidism treatment recalled; FDA warns about weight loss supplement; First retinopathy of prematurity treatment for preterm infants is approved.
The FDA make revisions to EUAs for COVID-19 antivirals; Study finds possible new indication for beta blockers; Jesduvroq approved; Artificial tears product under investigation; Evusheld emergency use authorization halted.
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.
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to Alzheimer disease treatment; New fixed-dose asthma treatment; NERD therapy looks promising; Leukemia drug to be withdrawn in 2023; Pertussis prevention treatment approved for use during pregnancy.
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