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Last updated on April 20, 2014 at 8:28 EDT

Latest GALILEO CRVO Stories

2014-02-24 08:27:50

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...

2013-12-18 08:28:42

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 is ten months from submission, for a target action...

2013-11-22 04:20:56

TARRYTOWN, N.Y., Nov. 22, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that EYLEA(®) (aflibercept) Injection has received approval for the treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO) from the Japanese Ministry of Health, Labour and Welfare. "We are pleased with the approval of EYLEA in Japan in the macular edema following CRVO indication, a significant cause of visual impairment in adults," said George D....

2013-10-21 08:28:31

TARRYTOWN, N.Y., Oct. 21, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results for EYLEA(®) (aflibercept) Injection from the Phase 3 VIBRANT study in patients with Macular Edema following Branch Retinal Vein Occlusion (BRVO). In this trial, 53% of patients who received EYLEA 2 milligram (mg) every four weeks gained at least 15 letters in vision from baseline at week 24, the primary endpoint of the study, compared to 27% of...

2013-09-17 16:23:57

TARRYTOWN, N.Y., Sept. 17, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that detailed results from the Phase 3 VIVID and VISTA trials of EYLEA(®) (aflibercept) Injection in Diabetic Macular Edema (DME) will be presented at an oral session during the upcoming annual meeting of the Retina Society to be held September 26-29 in Los Angeles, United States. These data will be presented on Friday, September 27, at 4:51 PM PDT. Separately, these data...

2013-08-29 04:21:08

TARRYTOWN, N.Y., Aug. 29, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that EYLEA(®) (aflibercept) Injection has been approved by the European Commission for the treatment of visual impairment due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO). "We are pleased with the approval of EYLEA in the E.U. in a second indication," said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of...

2013-07-26 08:25:53

TARRYTOWN, N.Y., July 26, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that EYLEA(®) (aflibercept) Injection has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of visual impairment due to Macular Edema secondary to Central Retinal Vein Occlusion (CRVO). The decision of the European Commission is expected in the second half of 2013. "We are pleased with the positive...

2013-06-06 04:20:54

TARRYTOWN, N.Y., June 06, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced positive top-line results for EYLEA(®) (aflibercept) Injection from the Phase 3 MYRROR study in myopic choroidal neovascularization (mCNV). In this trial, patients receiving EYLEA at an initial dose of 2 milligrams (mg), followed by treatment on an as-needed (PRN) basis, had a mean improvement in best-corrected visual acuity (BCVA) from baseline at week 24 of...

2012-12-06 04:23:31

TARRYTOWN, N.Y. and BERLIN, Dec. 6, 2012 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced that Bayer HealthCare has submitted an application for marketing authorization in Europe for EYLEA (aflibercept) Injection for the treatment of macular edema following Central Retinal Vein Occlusion (CRVO). "It is our pleasure to announce the filing for EYLEA for the macular edema following CRVO indication with the European Regulatory Authority...

2012-11-27 04:20:35

TARRYTOWN, N.Y., Nov. 27, 2012 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that EYLEA(®) (aflibercept) Injection has been approved by the European Commission for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD). According to the European Medicines Agency (EMA) approved Summary of Product Characteristics, EYLEA treatment is initiated with one 2 milligram (mg) injection per month for three consecutive months,...