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 ...
Federal Register notice: FDA announces a 3/28-29 public workshop entitled Understanding Priorities for the Development of Digital Health Technologies ...
Federal Register notice: FDA announces a 5/11 public workshop entitled FY 2023 Generic Drug Science and Research Initiatives Workshop.
FDA accepts for filing a Sandoz BLA for a biosimilar version of Amgens denosumab (Prolia and Xgeva), which includes all indications for the reference ...
