FDA Delays PDUFA On Human Genome Sciences, Inc. and GlaxoSmithKline Lupus Drug Benlysta
Pharmaceutical Business Review -- The US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target date for its priority review of Human Genome Sciences (HGS) and GlaxoSmithKline's (GSK) biologics license application (BLA) for Benlysta (belimumab) as a potential treatment for systemic lupus erythematosus (SLE) from 9 December 2010 to 10 March 2011.