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CDRH approves an updated postmarket study plan submitted by Bayer to assess safety and efficacy issues involving its controversial...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion cautions Celator that a convention panel misbrands its investigation cancer drug CPX-3...[ Price : $8.95]
FDA grants Sage Therapeutics a breakthrough therapy designation for SAGE-547 for treating postpartum depression.[ Price : $8.95]
Ariad Pharmaceuticals completes a rolling NDA submission for its investigational anaplastic lymphoma kinase (ALK) inhibitor, briga...[ Price : $8.95]
FDA grants Catalyst Pharmaceuticals an orphan drug designation for Firdapse (amifampridine phosphate) for treating myasthenia grav...[ Price : $8.95]
U.S. lawmakers question Mylans classification and rebate obligations under the Medicaid Drug Rebate Program for its controversial ...[ Price : $8.95]
CDRH allows under its de novo review the marketing of Concentric Medicals two Trevo clot retrieval devices as an initial therapy f...[ Price : $8.95]
FDA issues a final rule that bans 19 active ingredients including most commonly triclosan and triclocarban from use in over-the-...