Regeneron Pharmaceuticals‘ sBLA for Eylea has been accepted for standard review by the FDA. The sBLA is for the treatment of Diabetic Macular Edema (DME). The Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is 10 months from submission, for a target action date of August 18, 2014. The Eylea sBLA submission is based on the positive results from the Phase III VIVID and VISTA trials. Eylea was approved in the U.S. for the treatment of neovascular (wet) Age-r...