Latest GALILEO CRVO Stories
TARRYTOWN, N.Y., June 11, 2014 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced that Bayer HealthCare has submitted an application to the European Medicines Agency (EMA) seeking marketing authorization in the European Union (EU) for EYLEA(®) (aflibercept) Injection for the treatment of macular edema following branch retinal vein occlusion (BRVO). The EMA submission is based on the positive Phase 3 VIBRANT trial, a double-masked,...
TARRYTOWN, N.Y., Feb. 24, 2014 /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 Macular Edema following Branch Retinal Vein Occlusion (BRVO). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review of an sBLA is ten months from...
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