[ Price : $8.95]
Biovail submits a complete response to an FDA not approvable letter sent in July for its antidepressant BVF-033, a once-daily salt...[ Price : $8.95]
FDA publishes a draft guidance for industry on laboratory requirements that signal a new drugs potential to cause liver injury.[ Price : $8.95]
FDA issues a draft guidance to help sponsors and others develop in vitro diagnostic studies.[ Price : $8.95]
FDA issues Noven Pharmaceuticals an approvable letter on its NDA for Stavzor delayed-release capsules, a 505(b)(2) submission refe...[ Price : $8.95]
FDA grants fast track for Pharmassets R7128, an investigational therapy for treating chronic hepatitis C virus (HCV) infection.[ Price : $8.95]
Federal Register Notice: FDAs Nonprescription Drugs Advisory Committee will meet 12/14 to discuss the safety and effectiveness of ...[ Price : $8.95]
CDER warns Sanofi-Aventis over failures to properly conduct a Ketek clinical trial.[ Price : $8.95]
FDA says Cephalon has updated Provigils (modafinil) labeled warnings to include information on serious rashes, including Stevens-J...