FDA warns Taiwans Visgeneer, Inc., about Quality System and Medical Device Reporting violations in its manufacturing of blood glucose and blood uric a...
FDA issues an online post describing the safety to patients of the type of PFAS used in medical devices.
FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel; liso-cel) as a potential treatment for...
FDA accepts a Lantheus NDA for a new formulation of its Pylarify F 18 prostate-specific membrane antigen imaging agent.
FDA warns Glendora, CA-based Oasis Medical about CGMP violations in its production of finished drugs.
Right-wing commentator Laura Loomer publicly criticizes FDA commissioner Marty Makary over recent comments surrounding the departure and mooted return...
Former FDA chief of staff Elizabeth Jungman joins law firm Hogan Lovells as a partner in its pharmaceuticals and biotechnology practice in the Washing...
Vertex Pharmaceuticals says it will not pursue its investigational VX-993 as monotherapy for acute pain following bunionectomy surgery due to its fail...