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...
FDA clears a DePuy Synthes 510(k) for the VELYS Robotic-Assisted Solution and its use in unicompartmental knee arthroplasty.
FDA clears a Genetic Signatures 510(k) for its EasyScreen Gastrointestinal Parasite Detection Kit and GS1 automated workflow.
FDA leaves a one-item Form FDA-483 after an inspection last month at Cipla Ltd.s Maharasthra, India active pharmaceutical ingredient and finished dosa...
