Federal Register notice: FDA announces a 3/30 Peripheral and Central Nervous System Drugs Advisory Committee to discuss an Amylyx Pharmaceuticals NDA ...
Federal Register notice: FDA sets a 3/2 Device Good Manufacturing Practice Advisory Committee meeting to discuss and make recommendations on the curre...
FDA says a Vyaire Medical recall of 2,605 Bellavista ventilators due to a software configuration issue is Class 1.
FDA defers a 2/15 deadline on new annual drug manufacturing reporting that were mandated by the CARES Act to help the agency get a handle on potential...
University of Maryland researchers find substantial variability in information on sex-based differences in drug safety and efficacy for drugs approved...
Acadia Pharmaceuticals resubmits a supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associated with Alzheimers d...
FDA approves an Avita Medical PMA supplement for an enhanced version of its Recell system.
Robert Califf begins his second tour as FDA commissioner after being sworn in 2/17.