FDA releases guidance entitled Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) Modular Review.
FDA grants Rigel Pharmaceuticals an orphan drug designation for R289 and its use in treating myelodysplastic syndromes.
CDER director Patrizia Cavazzoni unexpectedly announces her early retirement effective two days before the new Trump administration comes to power.
Over 18,000 appalled physicians sign an open letter urging the U.S. Senate to reject the nomination of Robert F. Kennedy Jr. to serve as HHS secretary...
FDA accepts for review a Fortress Biotech NDA for CUTX-101 (copper histidinate) for treating Menkes disease.
Tenpoint Therapeutics reports positive topline results from BRIO-II, the companys second Phase 3 pivotal trial evaluating Brimochol PF (brimonidine) f...
FDA clears a CapsoVision 510(k) for its CapsoCam Plus capsule endoscopy system for remote ingestion.
Pfizer reports positive topline results from its pivotal Phase 3 CREST trial evaluating sasanlimab for combination use with Bacillus Calmette-Gurin in...
