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

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 ...

EYLEA ® (aflibercept) Injection 2 mg is a prescription medicine ... Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer ...

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

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

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

EYLEA® (aflibercept) Injection 2 mg is a prescription medicine ... Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer ...

Pushing the boundaries of science further to meet patient needs, EYLEA HD was developed to achieve comparable efficacy and safety to EYLEA, but with fewer injections. EYLEA HD is supported by a ...