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Federal Register notice: FDA announces a 10/31 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review a Vertex ...[ Price : $8.95]
FDA posts an update on changes being made to the 510(k) program through three draft guidances.[ Price : $8.95]
The FDA Office of New Drugs announces a two-day meeting on PET drug issues and concerns.[ Price : $8.95]
Janssen says its Rybrevant met its progression-free survival endpoint in the MARIPOSA-2 lung cancer trial.[ Price : $8.95]
FDA denies an ICAN petition asking for changes to labeling for acellular pertussis vaccines to say they do not prevent infection o...[ Price : $8.95]
FDA issues Alexion a complete response letter on a supplemental BLA for long-acting C5 complement inhibitor Ultomiris and its use ...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled DSCSA Standards for the Interoperable Exchange of Informati...[ Price : $8.95]
FDA approves Boston Scientifics latest generation of its Watchman FLX Pro Left Atrial Appendage Closure device.