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Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions for a NADA and ANADAs appro...[ Price : $8.95]
Writing in a The Hill opinion piece, Rep. Erik Paulsen (R-MN) says that reforming FDA is long overdue.[ Price : $8.95]
FDA approves an Ipsen Biopharmaceuticals supplemental NDA for Somatuline Depot (lanreotide) Injection 120 mg for treating carcinoi...[ Price : $8.95]
FDA posts annex guidance documents developed by the International Council for Harmonization of Technical Requirements for Pharmace...[ Price : $8.95]
Sanofi and Regeneron Pharmaceuticals announce positive results from the Phase 3 CAF study of Dupixent (dupilumab) in certain adult...[ Price : $8.95]
FDA issues a seven-item Form 483 after inspecting U.S. Specialty Formulations last month.[ Price : $8.95]
The U.S. government steps into an ongoing Biologics Price Competition and Innovation Act dispute (Amgen v. Sandoz), contending tha...[ Price : $8.95]
FDA approves CSL Behrings Privigen [immune globulin intravenous (human), 10% liquid] for treating adults with chronic inflammatory...