The list below provides information gathered from press announcements and other public notices about certain recalls of health fraud* – related products regulated by FDA. For […]

Delivery Method: VIA Electronic Mail Reference #: 320-25-29 Product: Drugs Recipient: Recipient Name Mr. David M. Rose Recipient Title CEO and Co-Owner Atlanta Supersource, Inc. 3655 […]

Mifeprex (mifepristone) and its generic, Mifepristone Tablets, 200 mg (collectively mifepristone) are approved, in a regimen with misoprostol, to end an intrauterine pregnancy through ten weeks […]

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 […]