[ 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]
Federal Register notice: FDA makes available a draft guidance #210 entitled The Index of Legally Marketed Unapproved New Animal Dr...[ Price : $8.95]
Federal Register notice: FDA makes available the safety and effectiveness summaries of recent PMAs approved by CBER.[ 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...[ Price : $8.95]
FDA approvea a Nesher Pharmaceuticals ANDA for the first generic version of Genentechs Tamiflu (oseltamivir phosphate) for oral su...