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...
FDA says there were 55 new drug shortages in CY 2023 and 236 potential shortages that were prevented through efforts by the agency, manufacturers, and...
Replimune plans a BLA submission for its RP1 therapy in combination with nivolumab for treating melanoma patients whove failed an anti-PD1 therapy.
