On August 31, 2021, the Food and Drug Administration approved zanubrutinib (Brukinsa, BeiGene) for adult patients with Waldenström’s macroglobulinemia (WM). Zanubrutinib was investigated in ASPEN (NCT03053440), […]

On January 17, 2025, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adult patients […]

Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership […]

Drug Development and Drug Interactions: Advisory Committee Meetings | FDA In this section: Drug Interactions & Labeling Home Drugs Development & Approval Process | Drugs Development […]

On January 16, 2025, the Food and Drug Administration approved sotorasib (Lumakras, Amgen Inc.) with panitumumab (Vectibix, Amgen Inc.) for adult patients with KRAS G12C-mutated metastatic colorectal […]

On January 16, 2025, the Food and Drug Administration granted traditional approval to acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for adults with previously untreated mantle […]

[1/16/2025] FDA is warning health care professionals not to use unapproved epinephrine nasal solutions manufactured by BPI Labs LLC, in Largo, Fla., and Endo USA, in Malvern, Pa. Health […]

On This Page Date: February 27, 2025 Time: 1:00 p.m. – 3:30 p.m. ET AGENDA Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT […]

PQ/CMC and HL7 FHIR In order to assist in understanding the development of the PQ/CMC implementation Guide using Fast Health Interoperable Resources (FHIR) which is a […]