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

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

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

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 ...

Biotech giant Regeneron Pharmaceuticals, Inc. REGN is slated to report first-quarter 2025 results on April 29, 2025. The ...

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

If approved, EYLEA HD would be the first and only treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period – halving the number of injections that are ...

Pharmaceuticals announced on Friday the Food and Drug Administration has issued a complete response letter regarding the ...

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

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 initial uptake of Eylea HD has been strong as Eylea patients transition to the higher dose. Sales of Eylea HD have likely surged in the to-be-reported quarter on strong demand. This ...