Novo Nordisk petitions FDA to take specific steps to follow through on the companys nomination of semaglutide (Rybelsus, Ozempic, Wegovy) to the lists...
FDA cautions Silliker contract testing laboratory about CGMP violations at its Gainesville, FL, facility.
FDA posts a draft guidance entitled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products.
FDA accepts for review an Aldeyra Therapeutics NDA for reproxalap, an investigational topical new drug candidate for treating signs and symptoms of dr...
FDA clears a BrightHeart 510(k) for its artificial intelligence software for reviewing prenatal ultrasound evaluations of the fetal heart to detect co...
FDA issues Takeda Pharmaceutical a four-item Form FDA-483 after inspecting the firms Yamaguchi, Japan manufacturing facility and finding GMP deficienc...
Federal Register notice: FDA permanently debars Ivette Maria Portela Martinez from providing services to a person that has an approved or pending drug...
Federal Register notice: FDA determines that Mercks Hydrocortone (hydrocortisone sodium phosphate) injection was not withdrawn due to safety or effect...
