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

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

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 ...

In the European Union and United Kingdom, aflibercept 8 mg (Eylea HD in the US) is currently approved for neovascular ...

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.

The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) Injection 8mg, submitted by US biotech ...

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 ...

EYLEA ® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion ...

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 ...