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

Regeneron Pharmaceuticals has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its Eylea HD eye drug.

plus a reduced need for injections into the eye with current therapy Eylea. On the strength of the results, 4DMT is planning to start a phase 3 trial of the gene therapy by the end of the first ...

The company’s products include EYLEA injection to treat wet age-related ... Further, it develops product candidates for treating patients with eye, allergic and inflammatory, cardiovascular ...

The three trials were all testing an experimental once-monthly dosing regimen for Beovu, which is already approved for wet AMD as an injection into the eye every ... Beovu to Eylea in 529 wet ...

Learn more about whether Alvotech or Halozyme Therapeutics, Inc. is a better investment based on AAII's A+ Investor grades, which compare both companies' key financial metrics.

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

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 US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application ...

FDA accepts Regeneron's sBLA for Eylea HD in RVO with priority review; QUASAR data supports monthly dosing, target action date set for August 2025.