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

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

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

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 ...

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

Regeneron aims for FDA approval of extended dosing for EYLEA HD in AMD and DME, with a decision by April 2025. Pre-filled ...

Investors' focus is likely to be on the performance of Dupixent and the uptake of Eylea HD when REGN reports first-quarter results on April 29.

EYLEA HD is approved with dosing intervals from every 8 to 16 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), and every 8 to 12 weeks for ...

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