[ Price : $8.95]
FDA extends by three months a Krystal Biotech BLA for B-Vec (beremagene geperpavec) after it submitted manufacturing data pursuant...[ Price : $8.95]
FDA accepts for priority review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for brexpiprazole for use in treating ag...[ Price : $8.95]
Federal Register notice: FDA announces a 2/15 advisory committee meeting to discuss an Emergent BioSolutions supplemental NDA for ...[ Price : $8.95]
FDA clears a CardiacSense 510(k) for its CSF-3 Watch for monitoring vital signs, such as electrocardiogram, beat-by-beat heart rat...[ Price : $8.95]
CDER dismisses any concern over the 26% drop in NDAs/BLAs approved in 2022, which saw approvals decline from 50 in 2021 to 37 last...[ Price : $8.95]
BioMarin Pharmaceutical says it is submitting to FDA additional long-term data (three years) as part of the ongoing BLA review for...[ Price : $8.95]
Zyno Medical agrees to pay $493,000 to resolve allegations that it violated the False Claims Act by causing the submission of clai...[ Price : $8.95]
FDA posts five device classifications that were requested under the agencys de novo program.