Docket Number: FDA-2022-D-0108 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability […]

Action FDA approved Poherdy (pertuzumab-dpzb) injection as an interchangeable biosimilar biological product to Perjeta (pertuzumab). Poherdy (pertuzumab-dpzb) is the first biosimilar approved for Perjeta (pertuzumab). Poherdy […]

AAM GRx+Biosims, North Bethesda, MD October 28, 2025 FDA Electronic Submissions (EXPO BOOTH) – Jonathan Resnick, Heather Crandall, Seyoum Senay, Megan Boals, Sajid Khan, Office of […]

On November 13, 2025, the Food and Drug Administration approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co. Ltd.) as an interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc.). […]

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 […]