If approved, Eylea would be the first treatment for RVO with 8-week dosing. The FDA target action date is Aug. 19, 2025.

Regeneron Pharmaceuticals (NASDAQ:REGN) said on Thursday that the U.S. FDA will be reviewing the supplemental biologics ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept injection 8mg for the treatment of macular edema following ...

The sBLA seeks approval for Eylea HD for both the treatment of macular edema following retinal vein occlusion, and for ...

Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks ...

EYLEA HD is a treatment for retinal vein occlusion (RVO) that allows for dosing every 8 weeks after initial monthly doses, potentially halving injections. What is the FDA's action date for EYLEA ...

The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application ...

Regeneron Pharmaceuticals has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its Eylea HD eye drug.

as measured by the Early Treatment Diabetic Retinopathy Study letter score. QUASAR is being operationalized by Bayer under a collaboration agreement with Regeneron. About Retinal Vein Occlusion ...

Regeneron aims for FDA approval of extended dosing for EYLEA HD in AMD and DME, with a decision by April 2025. Pre-filled ...

Bayer seeks EMA approval for aflibercept 8 mg for treatment of retinal vein occlusion: Berlin Thursday, April 10, 2025, 16:00 Hrs [IST] Bayer has submitted an application to the E ...

Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for EYLEA HD Injection 8 mg. The sBLA seeks ...