FDA grants Ipsen accelerated approval for Iqirvo (elafibranor) 80 mg tablets for treating primary biliary cholangitis in combination with ursodeoxycho...
Federal Register notice: FDA announces the renewal of its Obstetrics, Reproductive and Urologic Drugs Advisory Committee for an additional two years.
Federal Register notice: FDA announces the renewal of its Arthritis Advisory Committee for an additional two years.
FDA launches an Emerging Drug Safety Technology Meeting (EDSTM) program to assist industry in implementing artificial intelligence activities related ...
FDA approves an expanded use for GSKs Arexvy (respiratory syncytial virus vaccine, adjuvanted) for preventing RSV lower respiratory tract disease.
FDA clears two Abbott 510(k)s for over-the-counter continuous glucose monitoring systems Lingo and Libre Rio.
FDAs Peripheral and Central Nervous System Advisory Committee unanimously votes to recommend the approval of Eli Lillys donanemab-azbt to treat Alzhei...
FDA clears a Moon Surgical 510(k) for its Maestro surgical system.
