FDA seeks input 11/21 from its Cellular, Tissue, and Gene Therapies Advisory Committee about AstraZenecas Andexxa and an increased risk of thrombosis ...
GSK says its Phase 3 GLISTEN trial evaluating linerixibat in adults with a relentless itch associated with primary biliary cholangitis met its primary...
FDA warns New Delhi, India-based Unexo Lifesciences about CGMP and other violations in its production of finished drugs.
FDA warns Italys Originitalia about CGMP violations in its production of finished drugs.
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 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...
