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

The FDA did not approve the supplemental biologics license application for Eylea HD. The application would have added extended dosing intervals greater than 16 weeks, if approved. Editor’s note ...

At the J.P. Morgan Healthcare Conference in January, Regeneron CEO Leonard Schleifer said that the company’s new formulation of eye disease treatment Eylea needed “a few more arrows in its ...

The FDA has granted Priority Review status to Regeneron’s and Bayer’s supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) injection 8 mg. The application seeks to expand use ...

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, reducing the number of injections by half ...

“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 ...

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 ...

Regeneron Pharmaceuticals has announced the U.S. FDA's acceptance for Priority Review of the supplemental Biologics License Application for EYLEA HD (aflibercept) Injection 8 mg, which ...

The sBLA was supported by data from the Eylea HD clinical program which included the active-controlled, double-masked phase 3 QUASAR trial (ClinicalTrials.gov Identifier: NCT05850520). The trial ...

A significant chunk of Regeneron’s revenues comes from the sale of its lead drug, Eylea, which is approved for various ophthalmology indications (neovascular age-related macular degeneration ...

Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has accepted for Priority Review the supplemental ...