FDA warns Rogers, AR-based Dunagin Pharmaceuticals, which does business as Massco Dental, about CGMP violations in its manufacturing of finished drugs...
FDA warns Torrance, CA-based Cosmetic Science Laboratories about CGMP and other violations in its production of finished drugs as a contract manufactu...
CBER director Peter Marks tells a Muscular Dystrophy Association conference about ways FDA is addressing barriers to developing gene therapies for rar...
CDER submits a petition outlining its requests if the FDA chief scientist decides to grant Intarcia a hearing on its NDA for drug/device combination I...
Karuna Therapeutics plans a mid-year NDA for schizophrenia drug KarXT (xanomeline-trospium) after reporting positive topline results from a recent Pha...
FDA and RTI International researchers review empirical studies of prescription drug promotion in the last decade and suggest areas for further study.
FDA clears a Brainomix 510(k) for its Brainomix 360 e-ASPECTS artificial intelligence tool for stroke diagnoses.
FDA clears a Viz.ai 510(k) for its Viz AAA, an artificial intelligence algorithm intended to detect suspected abdominal aortic aneurysms.
