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FDA approves an Eli Lilly and Acrux NDA for Axiron (testosterone) topical solution applied to the armpit for replacement therapy i...[ Price : $8.95]
Genzyme says it has met the first milestone under its consent decree with FDA over GMP issues at its Allston, MA manufacturing fac...[ Price : $8.95]
FDA field investigators cite aseptic processing deficiencies at a Gilead San Dimas, CA manufacturing plant.[ Price : $8.95]
Micromedics recalls its Surgical Sealant Dispensers, Nasal Septal Buttons, and Otological Ventilation Tubes because the products a...[ Price : $8.95]
Gilead Sciences files an NDA for a combination pill containing Truvada and Tibotec Pharmaceuticals investigational non-nucleoside ...[ Price : $8.95]
Vertex says its telaprevir NDA submission is complete with results from three Phase 3 studies.[ Price : $8.95]
FDA approves a CNS Therapeutics NDA for Gablofen (baclofen injection) for use in managing severe spasticity.[ Price : $8.95]
FDAs Baltimore District Office warns Eastern Cranial on Quality System and other violations associated with its KidCap Cranial Mol...