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Last updated about 9 hours ago
Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
about 9 hours ago
Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended...
FDA approves first interchangeable biosimilar to Perjeta to treat certain types of breast cancer
1 day ago
FDA approves first interchangeable biosimilar to Perjeta to treat certain types of...
FDA approves new interchangeable biosimilar to Perjeta
1 day ago
On November 13, 2025, the Food and Drug Administration approved Poherdy (pertuzumab-dpzb...
FDA approves ziftomenib for relapsed or refractory acute myeloid leukemia with a NPM1 mutation
1 day ago
On November 13, 2025, the Food and Drug Administration approved ziftomenib (Komzifti...
Drug Development Considerations for the Treatment of Neonatal Enterovirus Infection and Congenital Cytomegalovirus Infection--Virtual Public Workshop - 05/07/2024
2 days ago
The Food and Drug Administration is holding a public, two-day workshop entitled...
Taizhou Kangping Medical Science and Technology Co., Ltd. - 711081 - 10/09/2025
3 days ago
CGMP/Finished Pharmaceuticals/Adulterated
FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies
4 days ago
Proposed removal of risk statements about cardiovascular diseases, breast cancer, and probable...
Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL Fill in a 2 mL Vial Due to Out-of-Specification Endotoxin Results in Certain Reserve Samples
7 days ago
FOR IMMEDIATE RELEASE – Nov. 6,2025 – LAKE ZURICH, Ill.— Fresenius Kabi...