Biogen and Public Citizen call on FDA to address issues in its draft guidance on developing drugs to treat early Alzheimers disease.
Israeli researchers say more effort must be made to increase the number of women enrolled in medical device clinical trials.
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.
