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.
FDA approves a Geron NDA for Rytelo (imetelstat) for treating certain adult patients with low- to intermediate-1 risk myelodysplastic syndromes.
Federal Register notice: CDER posts a proposal to refuse the approval of a supplemental NDA submitted by Vanda Pharmaceuticals for Hetlioz (tasimelteo...
Federal Register notice: FDA announces a 7/25 Oncologic Drugs Advisory Committee meeting to an AstraZeneca supplemental BLA for Imfinzi (durvalumab) i...
