Regeneron announces FDA acceptance of EYLEA sBLA Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for standard review the company's supplemental Biologics License Application for EYLEA Injection for the treatment of Diabetic Macular Edema. Under the Prescription Drug User Fee Act, the goal for a standard review of an sBLA is ten 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 3 VIVID and VISTA trials.
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Regeneron data strong according to doctors, says Deutsche Bank Deutsche Bank says its channel checks with doctors indicate Regeneron's Phase 2a data for Dupilumab in Atopic Dermatitis is strong. Deutsche estimates Regeneron's Atopic Dermatitis peak sales in the U.S. could be $3B. The firm calls Dupilumab "the next big thing" in Regeneron's portfolio and it keeps a Buy rating on the stock.