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Santarus plans to file an NDA with FDA in the second half of 2011 due to positive results from a Phase 3 European trial of budeson...[ Price : $8.95]
FDA accepts for review a GlaxoSmithKline response to an earlier agency-issued complete response letter on an NDA for Horizant (gab...[ Price : $8.95]
FDA says the vast majority of required post-marketing studies are proceeding on schedule.[ Price : $8.95]
American Regent voluntarily recalls one lot of its magnesium sulfate injection USP 50% (25g/50mL) due to the appearance of discolo...[ Price : $8.95]
The House Oversight and Government Reform Committee asks FDA for inspection records for all drug manufacturing facilities in Puert...[ Price : $8.95]
FDA clears a Carl Zeiss Meditec 510(k) for the IOLMaster 500, a biometer used to calculate all necessary eye measurements for cata...[ Price : $8.95]
FDA clears a Cook Medical 510(k) for the Evolution Controlled Release Esophageal Fully Covered Stent for use in esophageal cancer ...[ Price : $8.95]
An FDA conference on gene therapy and stem cell biology hears about significant increases in the number of trials, including 19 pe...