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

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

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

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

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

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

This was a low-key week for the biotech sector before the onset of the first-quarter earnings season. Biotech giant Bristol ...

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 ...

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 ...

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