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

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

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

FDA accepts Regeneron's sBLA for Eylea HD in RVO with priority review; QUASAR data supports monthly dosing, target action date set for August 2025.

Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted for Priority Review the supplemental ...

Regeneron Pharmaceuticals ( NASDAQ: REGN) said on Thursday that the U.S. FDA will be reviewing the supplemental biologics license application ( (sBLA)) for Eylea HD injection, 8 mg, to treat macular ...