On November 13, 2025, the Food and Drug Administration approved ziftomenib (Komzifti, Kura Oncology, Inc.), a menin inhibitor, for adults with relapsed or refractory acute myeloid […]

Delivery Method: Via Email Reference #: 320-26-01 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Yuegen Wang Recipient Title General Manager Taizhou Kangping Medical Science and […]

Delivery Method: VIA Electronic Mail Reference #: 320-26-13 Product: Drugs Recipient: Recipient Name Mr. Andrew Criglington Recipient Title Chief Executive Officer Miers Laboratories, Ltd 32 Waiu […]

Delivery Method: Via Email Product: Drugs Recipient: Recipient Name Danielle White Recipient Title President IBSPOT.com Inc. 1414 Willow AvenueElkins Park, PA 19027United States [email protected] Issuing Office: […]

Proposed removal of risk statements about cardiovascular diseases, breast cancer, and probable dementia from the Boxed Warnings, as well as other proposed safety-related labeling changes, to […]

Product: Drugs Recipient: Recipient Name Konrad Rejdak, M.D. Konrad Rejdak, MD, PhD Samodzielny Publiczny SzpitalKliniczny Nr 4 w Lublinie, ul. Jaczewskiego 8,20-090 LublinPoland [email protected] Issuing Office: […]

Summary Company Announcement Date: November 06, 2025 FDA Publish Date: November 07, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Out-of-specification endotoxin results Company […]

On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adults with high-risk smoldering multiple myeloma (SMM). […]

Docket Number: FDA-2017-D-0040 Issued by: Guidance Issuing Office Office of the Commissioner, Office of the Chief Medical Officer, Office of Combination Products This guidance is intended […]