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

QUASAR trial showed Eylea HD matched vision gains of standard Eylea with less frequent dosing. BofA cuts Regeneron price target to $547, maintains Underperform rating. Feel unsure about the market ...

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

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 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 ...

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

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 ...

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 ...

On April 17, Regeneron (REGN) Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for EYLEA HD ...