Docket Number: FDA-2011-D-0605 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research, Office of New Drugs, Office of Therapeutic Biologics and Biosimilars FDA is […]

On This Page Date: November 6, 2025 Time: 9:00 a.m. – 3:00 p.m. ET Location: Event Location FDA HeadquartersFDA White Oak Campus 10903 New Hampshire Ave, […]

On This Page Date: November 6, 2025 Time: 9:00 a.m. – 3:00 p.m. ET Location: Event Location FDA HeadquartersFDA White Oak Campus 10903 New Hampshire Ave, […]

Delivery Method: Via Electronic Mail – Delivery and Read Receipt Requested Reference #: 320-26-07 Product: Drugs Recipient: Recipient Name Mr. Robert Kibbe Recipient Title President and […]

On October 24, 2025, the Food and Drug Administration approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute myeloid leukemia with […]

Delivery Method: VIA UPS Reference #: 320-25-115 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Prakash C. Purohit Recipient Title President/Owner Naturich Cosmetique Labs 2505 Merritt […]

[10-23-2025] The Food and Drug Administration is advising consumers not to purchase or use SPARTAN, a product promoted and sold for male sexual enhancement on various […]

On October 23, 2025, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline), a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate, with bortezomib […]

76 218492 Prucalopride Tablets Novitium Pharma LLC Motegrity Tablets 12/26/2024 For the treatment of chronic idiopathic constipation in adults 75 215971 Deutetrabenazine Tablets Aurobindo Pharma Limited […]