CDER Electronic Submissions Presentations
AAM GRx+Biosims, North Bethesda, MDOctober 28, 2025FDA Electronic Submissions (EXPO BOOTH) – Jonathan Resnick, Heather Crandall, Seyoum Senay, Megan Boals, Sajid Khan, Office of Business Informatics, CDERAAM GRx+Biosims, North Bethesda, MDOctober 21, 2024eCTD v4...FDA Encourages Public to Follow Established Choking Rescue Protocols
Español 简体中文 (Simplified Chinese) Tagalog Update: November 13, 2025The FDA has taken actions to address the marketing of unauthorized anti-choking devices, including issuing Warning Letters and an Import Alert. Additional information is provided below under the FDA...FDA approves new interchangeable biosimilar to Perjeta
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.). This is the first approval of a biosimilar for Perjeta.Poherdy is a...FDA approves ziftomenib for relapsed or refractory acute myeloid leuke
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 leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no...Food To Live Voluntarily Recalls Organic Moringa Products Because of Possible Health Risk
Summary Company Announcement Date: November 12, 2025 FDA Publish Date: November 13, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Salmonella Company Name: Food To Live...Treatment of Congenital Cytomegalovirus Neonatal Enterovirus Infection
On This Page Date: May 7 – 8, 2024 Day1: Tue, May 07 9:00 a.m. – 05:00 p.m. ET Day2: Wed, May 08 9:00 a.m. – 05:00 p.m. ET DESCRIPTION AND SUMMARY The Food and Drug Administration is holding a public, two-day workshop entitled “Development of Drugs...ByHeart Broadens Voluntary Recall While Investigation Continues
Summary Company Announcement Date: November 11, 2025 FDA Publish Date: November 11, 2025 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Foodborne Illness – Clostridium botulinum Company Name: ByHeart...Miers Laboratories, Ltd – 715378
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 Street, Wainuiomata Lower HuttWellington 5014New Zealand...Click To Verify Security & Validation
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