FDA alerts clinical laboratory staff and health care providers about the potential impact of viral mutations, including an emerging variant from the U...
FDA continues its review of a Bristol-Myers Squibb BLA for lisocabtagene maraleucel (liso-cel), indicated for treating adults with relapsed or refract...
FDA grants Gemini Therapeutics a fast track designation for GEM103, an investigational treatment for dry, age-related macular degeneration.
Federal Register notice: FDA issues an order to permanently debar former Insys Therapeutics regional sales manager Joseph A. Rowan.
Federal Register notice: FDA issues an order to permanently debar former Insys Therapeutics regional sales manager Sunrise Lee.
FDA grants RedHill Biopharma a fast track designation for RHB-204 and its use as a potential first-line, stand-alone, oral treatment for pulmonary non...
FDA grants Functional Neuromodulation a breakthrough device designation for the Vercise Deep Brain Stimulation System for treating patients 65 years a...
Tidepool files a 510(k) for an automated insulin dosing app for use on the iPhone for managing Type 1 diabetes.