November 13, 2025
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 […]
November 13, 2025
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.). […]
November 13, 2025
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 […]
November 12, 2025
Share on PinterestThe FDA will remove black box warning labels on HRT products, which the agency states has sown confusion around hormone therapy for menopause. Lupe […]
November 12, 2025
Share on PinterestAcetaminophen is the safest option for pain relief and lowering fever during pregnancy. Anfisa&friends/Stocksy A new research review disputes claims made by the Trump […]
November 11, 2025
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 […]
November 11, 2025
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: […]
November 11, 2025
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 […]
November 11, 2025
Share on PinterestA new clinical trial found that coffee drinkers with AFib had a significantly lower risk of recurrence. Boy_Anupong/Getty Images A new clinical trial challenges […]
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