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.
FDA clears a Tandem Diabetes Care 510(k) for bolus insulin dosing on the t:slim X2 insulin pump using the t:connect mobile app.
Federal Register notice: FDA seeks comments about antimicrobial drug use practices in companion animals and the potential impacts on antimicrobial res...