Federal Register notice: FDA seeks comments concerning recommendations by the World Health Organization to impose international manufacturing and dist...
Philips North America recalls its BrightView computed tomography gamma camera system because of the risk of the detector unexpectedly falling.
FDA sets a 10/8 PDUFA action date for a Bristol Myers Squibb sNDA for Opdivo to treat some non-small cell lung cancers.
Amneal Pharmaceuticals resubmits an NDA for IPX203, a novel oral formulation of carbidopa/levodopa extended-release capsules for treating Parkinsons d...
FDA accepts for priority review an Amgen supplemental BLA for Blincyto (blinatumomab) for treating early-stage, CD19-positive B-cell precursor acute l...
Four Hogan Lovells attorneys say medical device companies should begin now to prepare for the implementation of FDAs new Quality Management System Reg...
Office of Generic Drugs associate director of stakeholder and global engagement Sarah Ibrahim says FDA and EMA are evaluating a new pilot parallel sci...
Gilead Sciences discontinues its Phase 3 ENHANCE-3 study of magrolimab in acute myeloid leukemia (AML) after FDA placed a clinical hold on it due to a...
