FDA warns Berkeley, CA-based Libby Laboratories about CGMP violations in its manufacturing of finished drugs.
University of Illinois law school scholar Sara Gerke calls for FDA to create AI Facts labeling for artificial intelligence-powered medical devices.
A Foundation for Defense of Democracies paper calls on FDA to correct a gap in a recent guidance that makes in-use medical devices vulnerable to cyber...
Rhythm Pharmaceuticals reports positive topline results from its Phase 2 trial evaluating bivamelagon in patients with acquired hypothalamic obesity.
FDA clears an Exactech 510(k) for the Equinoxe Scapula Reconstruction System for treating acromial and scapular spine fractures.
A Washington federal judge says FDA acted lawfully in imposing restrictions on the availability of chemical abortion drugs mifepristone and misoprosto...
AirLife and Vyaire recall certain infant heated wire circuits due to the risk that accessory adapters may unintentionally disconnect during setup or u...
FDA grants Trethera a fast track designation for TRE-515 for treating prostate cancer.
