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

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 ...

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 ...

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 ...

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

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 ...

Regeneron (REGN) announces FDA review of sBLA for Eylea HD to treat macular edema and expand dosing. Read more here.

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

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

BRIDGEWATER, N.J. and BENGALURU, Karnataka, India, April 15, 2025 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon ...