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FDA warns MedArt about Medical Device Reporting and Quality System violations found in an inspection at a company manufacturing fa...[ Price : $8.95]
FDA clears a Lensar 510(k) for its laser system for use in executing corneal incisions during cataract surgery.[ Price : $8.95]
CDER Office of New Drugs director John Jenkins says the first-cycle approval rate in 2012 is at the highest level in 20 years.[ Price : $8.95]
Exact Sciences Corp. files the first PMA module for its stool DNA colorectal cancer screening test.[ Price : $8.95]
Federal Register Notice: FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet 1/10/13 to discuss Janssens NDA for ...[ Price : $8.95]
Federal Register Notice: FDAs Cellular, Tissue and Gene Therapies Advisory Committee will meet 1/15/13 to discuss intramural resea...[ Price : $8.95]
Boehringer Ingelheim Pharmaceuticals reports positive preliminary results of a Phase 2 study of volasertib in newly diagnosed pati...[ Price : $8.95]
Celldex Therapeutics says final results from its Phase 2b EMERGE study of CDX-011 supports overall survival benefit in advanced br...