Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application Provided by GlobeNewswire Apr 18, 2025, 12:00:22 PM ...

Regeneron Pharmaceuticals announced positive three-year results from an extension study of EYLEA HD (aflibercept) Injection 8 mg for treating wet age-related macular degeneration (wAMD).

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors.

EYLEA HD demonstrated non-inferior vision gains with an every 8-week dosing regimen compared to EYLEA® (aflibercept) Injection 2 mg dosed every 4 weeks Safety data remains consistent with the known ...

The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application (sBLA) for Eylea HD (aflibercept) injection 8mg for priority review.

Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application Regeneron Pharmaceuticals, Inc. - GlobeNewswire - Fri Apr 18, 2:00PM CDT ...

TARRYTOWN, N.Y., April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response ...

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 ...

About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases.

About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases.