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Federal Register Notice: The Office of Management and Budget approves a collection of information on a guidance on formal dispute ...[ Price : $8.95]
FDA accepts a Pozen NDA for Vimovo (enteric-coated naproxen and immediate-release esomeprazole magnesium) for treating the signs a...[ Price : $8.95]
FDA approves a pediatric indication for and a pediatric oral solution formulation of Roches Valcyte.[ Price : $8.95]
FDA publishes a guidance to help industry comply with labeling requirements in the Dietary Supplement and Nonprescription Drug Con...[ Price : $8.95]
FDA approves a Eurand NDA for Zenpep delayed-release capsules for treating pancreatic insufficiency in patients with cystic fibros...[ Price : $8.95]
FDA asks the Oncologic Drugs Advisory Committee whether Genzyme should have to conduct a randomized controlled Clolar trial to sup...[ Price : $8.95]
FDA approves Takedas EXAMINE study design to determine cardiovascular outcomes for its Type 2 diabetes drug alogliptin.[ Price : $8.95]
FDA grants Families of Spinal Muscular Atrophy an orphan drug designation for quinazoline495 for treating spinal muscular atrophy.