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FDA approves a Lutonix PMA for its 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter, the first drug-coated b...[ Price : $8.95]
FDA publishes a final guidance on New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.[ Price : $8.95]
FDA approves a Gilead NDA for Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus genotype 1 infection.[ Price : $8.95]
Amgen says a Phase 3 study evaluating it biosimilar candidate ABP 501 compared with Abbotts Humira (adalimumab) in patients with m...[ Price : $8.95]
CBER says RTI Surgical is violating human tissue and biologic regulations in its map3 Chips Allograft.[ Price : $8.95]
FDA tells Shire PLC that additional pediatric data would be required when it resubmits an NDA for SHP 465 (triple-bead mixed amphe...[ Price : $8.95]
FDA approves Millenniums Velcade (bortezomib) for injection for use in previously untreated patients with mantle cell lymphoma.[ Price : $8.95]
Federal Register Notice: FDA releases an ICH guidance on pharmacovigilance of veterinary medicinal products and controlled list of...