Rep. Jake Auchincloss calls on FDA to affirm or refute his conclusion that the Commissioners National Priority Voucher program may not be legal becaus...
An FDA-authored journal article signals a supportive but cautious regulatory posture toward the development of chimeric antigen receptor T-cell therap...
FDA issues an early alert to warn clinicians about a potentially high-risk issue affecting certain Abiomed heart pump devices used to support patients...
FDA grants AstraZeneca and Daiichi Sankyo a priority review for their antibodydrug conjugate Datroway (datopotamab deruxtecan) as a potential first-li...
HHS Office of Inspector General begins an ethics investigation into FDA deputy chief of staff Samuel Doran and whether he misled the federal governmen...
FDA sends Aquestive Therapeutics a complete response letter for its NDA for Anaphylm, a sublingual epinephrine film for treating Type I allergic react...
A patient safety advocacy group files a citizen petition urging FDA to create a comprehensive public database of medical device labels.
New York Attorney General Letitia James and a bipartisan coalition of 47 other attorneys general secure $17.85 million from drug manufacturers Bausch ...
