Regeneron Pharmaceuticals (NASDAQ:REGN) said on Thursday that the U.S. FDA will be reviewing the supplemental biologics license application ((sBLA)) for Eylea HD injection, 8 mg, to treat macular ...

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 ...

Regeneron's first-quarter results missed Wall Street estimates on Tuesday due to stiff competition for its blockbuster drug ...

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 ...

which is the maximum dosing interval currently indicated in the label). Nonetheless, the FDA accepted the sBLA for Eylea HD injection 8 mg. The sBLA seeks approval for Eylea HD to treat macular ...

Regeneron books full US Eylea sales, and 80% of its Eylea-related ... costs related to product governance ESG risks (such as off-label marketing or litigation related to side effects), and model ...

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. Learn the top momentum ...

Regulatory delays impacting EYLEA HD’s pre-filled syringe approval could hinder adoption. Increased market share of off-label Avastin poses a challenge to the anti-VEGF category. Analysts raised ...

said on Thursday that the U.S. FDA will be reviewing a supplemental biologics license application ((sBLA)) for its eye disease drug Eylea HD injection, 8 mg, to expand its label and to broaden its ...