CDER announces that a planned Office of Generic Drugs reorganization has been approved and will be implemented later this year.
Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting consumer representative...
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...