Federal Register notice: FDA announces a 2/15 advisory committee meeting to discuss an Emergent BioSolutions supplemental NDA for Narcan (naloxone HCl...
FDA clears a CardiacSense 510(k) for its CSF-3 Watch for monitoring vital signs, such as electrocardiogram, beat-by-beat heart rate, and oxygen satura...
FDA accepts a Roche BLA for priority review for glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody for treating certain adult...
CDER director Patrizia Cavazzonitries to restore credibility within her Center by announcing the accelerated approval for a Biogen/Eisai BLA for lecan...
Hospira recalls one lot of injectable vancomycin HCl single-dose fliptop 1.5 g vials due to two visible glass particulates observed in a single vial.
FDA posts five device classifications that were requested under the agencys de novo program.
The recent omnibus legislation extends a drug company safe harbor to medical device companies on sharing health care economic information, according t...
An FDA update says AstraZenecas Evusheld may not neutralize the new Covid-19 variant XBB.1.5.
