Genentech submits a supplemental NDA for Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) in people with previously untreated chronic ...
FDA says it will no longer require that a suffix be added to the nonproprietary names of existing biological products.
FDA accepts for review a Foamix Pharmaceuticals NDA for FMX101 (minocycline foam, 4%) for treating inflammatory lesions of non-nodular moderate-to-sev...
Federal Register notice: FDA announces a 4/8 Pediatric Advisory Committee meeting to discuss drug development for testosterone replacement therapy in ...
A Kaiser Health News investigative report spotlights FDAs medical device adverse report alternative databases that are hidden from public view.
MITA raises four issues for FDA to consider for its software precertification program.
FDA grants Paige.AI a breakthrough device designation for its artificial intelligence tools to help physicians diagnose and treat cancer.
The Medical Device Innovation Consortium releases a somatic reference sample landscape analysis report.