Johnson & Johnson says an independent data monitoring committee recommended unblinding the MajesTEC-3 study of Tecvayli and Darzalex Faspro following ...
Hyman, Phelps & McNamara principal medical device regulation expert Adrienne Lenz says FDA is preparing for a future where artificial intelligence and...
FDA urges the Supreme Court to reject Vanda Pharmaceuticals petition challenging the agencys decision to deny fast-track status for its experimental d...
FDA releases the form FDA-483 with three observations from its inspection at the Lupin drug manufacturing facility in Pithampur, Madhya Pradesh, India...
Minovia Therapeutics wins an FDA orphan drug designation for its lead investigational therapy, MNV-201, for myelodysplastic syndrome.
FDA accepts for review a Chiesi NDA for a single-inhaler triple therapy designed for the maintenance treatment of asthma in adults.
Charles River Laboratories names former FDA principal deputy commissioner Namandj N. Bumpus as chair a new global scientific advisory board to guide t...
FDA warns of serious complications associated with certain uses of radiofrequency microneedling devices, commonly used in aesthetic skin treatments.