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FDA Approves Symbiomix Antibiotic for Vaginosis

[ Price : $8.95]

FDA approves a Symbiomix Therapeutics NDA for Solosec (secnidazole) 2g oral granules for treating bacterial vaginosis in adult wom...

Medtronic PMA Approved for Intellis Pain Device

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FDA approves a Medtronic PMA for its Intellis platform for managing certain types of chronic intractable pain.

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...

Guide on Index of Unapproved New Animal Drugs

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Federal Register notice: FDA makes available a draft guidance #210 entitled The Index of Legally Marketed Unapproved New Animal Dr...

PMA Summaries Available for CBER-approved Products

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Federal Register notice: FDA makes available the safety and effectiveness summaries of recent PMAs approved by CBER.

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.