FDA says it is working with the CDC to investigate cases of TB associated with a bone matrix product.
Federal Register notice: FDA releases three draft guidances that are intended to improve the predictability, consistency, and transparency of the 510(...
Federal Register notice: FDA announces a 10/31 Cellular, Tissue, and Gene Therapies Advisory Committee meeting to review a Vertex Pharmaceuticals BLA ...
FDA posts an update on changes being made to the 510(k) program through three draft guidances.
The FDA Office of New Drugs announces a two-day meeting on PET drug issues and concerns.
Janssen says its Rybrevant met its progression-free survival endpoint in the MARIPOSA-2 lung cancer trial.
FDA denies an ICAN petition asking for changes to labeling for acellular pertussis vaccines to say they do not prevent infection or transmission of pe...
FDA issues Alexion a complete response letter on a supplemental BLA for long-acting C5 complement inhibitor Ultomiris and its use in treating certain ...
