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FDA accepts for review a Medicure supplemental NDA for Aggrastat (tirofiban HCl) that seeks an expanded indication to include trea...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Recommendations for Assessment of Blood Donor Suitability, Donor Deferral ...[ Price : $8.95]
Public Citizen calls on FDA to quickly finalize its proposed rule to allow generic drug manufacturers to update safety warnings wi...[ Price : $8.95]
FDAs Psychopharmacologic Drugs Advisory Committee votes to not recommend approval for a Fabre-Kramer Pharmaceuticals NDA for gepir...[ Price : $8.95]
Zafgen says a second death has been reported in a Phase 3 trial of beloranib in patients with Prader-Willi syndrome.[ Price : $8.95]
FDA says Insulet Corp. has issued a lot-specific voluntary Field Safety Notification for 15 lots of its OmniPod insulin deliverty ...[ Price : $8.95]
A Bipartisan Policy Center report calls on FDA to create a new regulatory pathway that would promote the use of cellular therapy i...[ Price : $8.95]
FDA announces a two-day (1/20-21/16) public workshop entitled Moving Forward: Collaborative Approaches to Medical Device Cybersecu...