Writing in a The Hill opinion piece, Rep. Erik Paulsen (R-MN) says that reforming FDA is long overdue.
FDA approves an Ipsen Biopharmaceuticals supplemental NDA for Somatuline Depot (lanreotide) Injection 120 mg for treating carcinoid syndrome.
FDA posts annex guidance documents developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Us...
Sanofi and Regeneron Pharmaceuticals announce positive results from the Phase 3 CAF study of Dupixent (dupilumab) in certain adults with moderate-to-s...
FDA issues a seven-item Form 483 after inspecting U.S. Specialty Formulations last month.
The U.S. government steps into an ongoing Biologics Price Competition and Innovation Act dispute (Amgen v. Sandoz), contending that the Act preempts a...
FDA approves CSL Behrings Privigen [immune globulin intravenous (human), 10% liquid] for treating adults with chronic inflammatory demyelinating polyn...
FDA approvea a Nesher Pharmaceuticals ANDA for the first generic version of Genentechs Tamiflu (oseltamivir phosphate) for oral suspension, indicated ...