An FDA Early Alert says Medline ReNewal recommends that some reprocessed St. Jude electrophysiology catheters be quarantined due to the possibility th...
FDA grants accelerated approval for Jazz Modeyso to treat diffuse midline glioma.
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...
