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Intarcia Therapeutics files an NDA for ITCA 650 (exenatide) for treating Type 2 diabetes.[ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Medtronics Core Valve System for patent extension purpose...[ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Pharming Groups Ruconest for patent extension purposes 3...[ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Celgenes Cerdelga (eliglustat) for patent extension purpo...[ Price : $8.95]
Federal Register Notice: FDA makes available a draft guidance entitled E11(R1) Addendum: Clinical Investigation of Medicinal Produ...[ Price : $8.95]
FDA warns Indias Srikem Laboratories about CGMP violations and data integrity issues in its manufacturing of active pharmaceutical...[ Price : $8.95]
FDA issues two guidances on GRASE determinations for OTC sunscreen products.[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites NutriResearch, Pine Pharmaceuticals, Physician Therapeutics, Srikem Laboratories...