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

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License ...

Regeneron's oncology platform is poised to be a significant growth driver in the next decade. Read why REGN stock remains a ...

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

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.

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

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

Regeneron Pharmaceuticals has announced the U.S. FDA's acceptance for Priority Review of the supplemental Biologics License Application for EYLEA HD (aflibercept) Injection 8 mg, which ...

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 ...

The FDA has granted Priority Review status to Regeneron’s and Bayer’s supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) injection 8 mg. The application seeks to expand use ...

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