FDA posts a revised guidance entitled Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During ...
Three Cooley attorneys say a recent Court of Appeals for the Federal Circuit decision shows how giving inconsistent information to FDA and the U.S. Pa...
FDA accepts for review an Axsome Therapeutics NDA for AXS-07 (meloxicam-rizatriptan) for treating migraine headaches.
FDA grants Nyxoah a breakthrough device designation for its Genio bilateral hypoglossal nerve stimulation system and its use in treating patients with...
FDA clears Anika Therapeutics Tactoset for an expanded indication.
FDA removes a clinical hold against KalVista Pharmaceuticals and its Phase 2 clinical trial of KVD824 for oral prophylactic treatment of hereditary an...
Researchers say they see no evidence of continuing problems with generic drug 180-day exclusivity parking that require a congressional solution.
Astellas says an ASPIRO trial patient whose serious adverse event led to the trial being paused and an FDA clinical hold has died.