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)
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am
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Source: Yahoo! Finance
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. The sBLA is supported by data from across the EYLEA HD clinical program, including the Phase 3 QUASAR trial investigating EYLEA HD in RVO.
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REGN
Earnings
- 10/28/25 - Beat
REGN
Sec Filings
- 12/11/25 - Form 4
- 12/11/25 - Form 4
- 12/11/25 - Form 4
- REGN's page on the SEC website