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 year.
BioMarin Pharmaceutical says it is submitting to FDA additional long-term data (three years) as part of the ongoing BLA review for Roctavian (valoctoc...
Zyno Medical agrees to pay $493,000 to resolve allegations that it violated the False Claims Act by causing the submission of claims to Medicare invol...
Federal Register notice: FDA sends to OMB an information collection extension entitled Reporting Associated with Designated New Animal Drugs for Minor...
Federal Register notice: FDA sends to OMB an information collection extension entitled Cellular and Tissue-Based Product Deviations in Manufacturing; ...
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...
