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FDA Amends Animal Drug Regs to Reflect Approvals

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Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions for a NADA and ANADAs appro...

Rep. Paulsen Calls for FDA Reforms

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Writing in a The Hill opinion piece, Rep. Erik Paulsen (R-MN) says that reforming FDA is long overdue.

Ipsen sNDA for Somatuline Depot Approved

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FDA approves an Ipsen Biopharmaceuticals supplemental NDA for Somatuline Depot (lanreotide) Injection 120 mg for treating carcinoi...

FDA Posts ICH Annex Quality Guides for Drug Makers

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FDA posts annex guidance documents developed by the International Council for Harmonization of Technical Requirements for Pharmace...

Sanofi/Regeneron Report Positive Phase 3 Results with Dupixent

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Sanofi and Regeneron Pharmaceuticals announce positive results from the Phase 3 CAF study of Dupixent (dupilumab) in certain adult...

FDA Posts 7-item Form 483 for U.S. Specialty Formulations

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FDA issues a seven-item Form 483 after inspecting U.S. Specialty Formulations last month.

U.S. Government Weighs in on Biosimilar Dispute

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The U.S. government steps into an ongoing Biologics Price Competition and Innovation Act dispute (Amgen v. Sandoz), contending tha...

FDA Approves CSL Behrings Privigen

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FDA approves CSL Behrings Privigen [immune globulin intravenous (human), 10% liquid] for treating adults with chronic inflammatory...

FDA Approves 1st Generic Tamiflu

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FDA approvea a Nesher Pharmaceuticals ANDA for the first generic version of Genentechs Tamiflu (oseltamivir phosphate) for oral su...

FDA Approves Broader Briviact Use in Epilepsy Patients

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FDA approves a UCB supplemental NDA for Briviact (brivaracetam) as monotherapy for partial-onset (focal) seizures in patients 16 y...