American Health Packaging recalls one lot of valsartan tablets,160 mg , due to the detection of trace amounts of an unexpected carcinogen in the finis...
FDA clears a Zeiss Medical Technology 510(k) for the Cirrus HD-OCT platform, expanding the capabilities of its anterior segment premier module to incl...
FDA grants Genentech accelerated approval for Tecentriq (atezolizumab) plus chemotherapy (Abraxane [paclitaxel protein-bound particles for injectable ...
FDA accepts for priority review a Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately con...
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 ...