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

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

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 ...

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

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

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

Lined up for the FDA in the coming weeks are a cell-based gene therapy for a rare skin disease and two product expansions for ...

Yesafili, a vascular endothelial growth factor inhibitor, is used to treat several different types of ophthalmology ...

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 ...

Regeneron Pharmaceuticals, Inc. discovers, invents, develops, manufactures, and commercializes medicines for treating various diseases worldwide. The company’s products include EYLEA injection ...