FDA issues Johnson & Johnson a complete response letter for its supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in a quadrup...
FDA approves an Instylla PMA for its Embrace Hydrogel Embolic System, a liquid embolic device for treating hypervascular tumors in peripheral arteries...
FDA says it will allow up to 12 months for doctors to transition patients who are taking unapproved animal-derived thyroid medications to approved syn...
Eli Lilly says it will file an NDA by the end of the year for its investigational obesity treatment orforglipron, based on just-announced Phase 3 data...
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.
