Regeneron Announces FDA Acceptance of EYLEA® (aflibercept) Injection Supplemental Biologics License Application for Review for Diabetic Macular Edema Indication
TARRYTOWN, N.Y., Dec. 18, 2013 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review the Company’s supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection for the treatment of Diabetic Macular Edema (DME). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA […]