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EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing in Approv...

Regeneron Pharmaceuticals, Inc. (REGN)  More Company Research Source: GlobeNewswire
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am Check Earnings Report
US:NASDAQ Investor Relations: investor.regeneron.com
If approved, EYLEA HD would be the first and only treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period – halving the number of injections that are indicated for all other anti-VEGF therapies Potential for as frequent as monthly dosing for all approved indications would provide greater dosing flexibility for physicians and patients TARRYTOWN, N.Y., April 17, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for EYLEA HD® (aflibercept) Injection 8 mg. The sBLA seeks approval for EYLEA HD for both the treatment of macular edema following retinal vein occlusion (RVO), and for broadening the dosing schedule to include every 4-week (monthly) dosing across approved indications. The FDA target action date is August 19, 2025, following the use of a Priority Review voucher. T [Read more]
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Stockreport

EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing in Approv...

Regeneron Pharmaceuticals, Inc.  (REGN) 
More Company Research Source: GlobeNewswire
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am Check Earnings Report
US:NASDAQ Investor Relations: investor.regeneron.com
If approved, EYLEA HD would be the first and only treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period – halving the number of injections that are indicated for all other anti-VEGF therapies Potential for as frequent as monthly dosing for all approved indications would provide greater dosing flexibility for physicians and patients TARRYTOWN, N.Y., April 17, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for EYLEA HD® (aflibercept) Injection 8 mg. The sBLA seeks approval for EYLEA HD for both the treatment of macular edema following retinal vein occlusion (RVO), and for broadening the dosing schedule to include every 4-week (monthly) dosing across approved indications. The FDA target action date is August 19, 2025, following the use of a Priority Review voucher. T [Read more]
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REGN
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