FDA revises its online guide on when and how often people should use an over-the-counter at-home Covid-19 test to encourage users to self-report their...
FDA approves a Takeda supplemental BLA for an expanded use of Takhzyro (lanadelumab-flyo) prophylaxis to prevent attacks of hereditary angioedema in ...
Federal Register notice: FDA determines that 31 drug products were not withdrawn from sale due to safety or effectiveness reasons.
FDA accepts for priority review a Biogen and Sage Therapeutics, NDA for zuranolone, a rapid-acting once daily oral drug for major depressive disorder ...
A citizen petition from the Clinical Decision Support (CDS) Coalition urges FDA to rescind its controversial 9/2022 final guidance on Clinical Decisio...
Former physician Deepak Raheja (Hudson, Ohio) gets 30 months in prison after pleading guilty to pharmaceutical kickback conspiracy charges involving t...
FDA approves an Abbott expanded indication for its FlexAbility Ablation Catheter, Sensor Enabled, a flexible tip catheter intended to help physicians ...
FDA approves AstraZeneca and Amgens asthma drug Tezspire (tezepelumab) in a self-administration pre-filled, single-use pen for patients aged 12 years ...