Federal Register notice: FDA withdraws approval of an NDA for Bufferin (aspirin) tablets because the application holder has failed to file required an...
FDA approves an Emergent BioSolutions BLA for Cyfendus (anthrax vaccine adsorbed, adjuvanted) for anthrax post-exposure prophylaxis.
Former medical device regulatory affairs specialist Peter Stoll pleads guilty on one felony count for distributing medical devices without FDA clearan...
CDER Counterterrorism and Emergency Coordination Staff director Rosemary Roberts announces her retirement this month.
The Biotechnology Innovation Organization says FDAs new Rare Disease Endpoint Advancement Pilot Program will provide greater clarity on how to develop...
FDA signs off on a Becton, Dickinson 510(k) that was filed over two years ago to update the firms troubled BD Alaris Infusion System.
FDA releases the form FDA-483 with one observation from an inspection at Chinas Wuxi Sta Pharmaceutical contract manufacturing organization.
Abiomed recalls all lots of six models of its Impella heart pump due to a potential risk for impeller blade destruction.
