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.
FDA approves an updated dosing schedule for Eli Lillys Alzheimers therapy Kisunla (donanemab-azbt) to reduce the risk of a known side effect called am...
FDA warns Vineyard, UT-based Dynamic Blending Specialists about multiple violations in its work as a contract manufacturer of over-the-counter drug pr...
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.
