GlaxoSmithKline And Human Genome Sciences Announce FDA Extension Of Benlysta® PDUFA T

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GlaxoSmithKline PLC (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target date for its priority review of the Biologics License Application (BLA) for Benlysta® (belimumab) as a potential treatment for systemic lupus erythematosus (SLE) from 9th December 2010 to 10th March 2011. After the FDA Arthritis Advisory Committee met on 16 November 2010 to consider the Benlysta BLA , the FDA requested some additional information from HGS, which has been submitted...


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