The FDA has sent Regeneron a complete response letter, rejecting its bid to stretch the administration of high-dose Eylea ...

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

The FDA issued a complete response letter for a supplemental biologics license application, in which it did not approve ...

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

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

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

Baird lowered the firm’s price target on Regeneron (REGN) to $652 from $759 and keeps a Neutral rating on the shares. The firm said its Eylea ...

The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application ...

The complete response letter did not identify any issues with the safety or efficacy of Eylea HD, Regeneron officials said.

The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up ...

The CRL did not identify any issues with the safety or efficacy of EYLEA HD in its approved indications and dosing regimens. The FDA did not agree with Regeneron’s proposal to add additional ...