FDA extends by three months a Krystal Biotech BLA for B-Vec (beremagene geperpavec) after it submitted manufacturing data pursuant to an agency inform...
FDA accepts for priority review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for brexpiprazole for use in treating agitation associated w...
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.
