Guidance language shifted to highlight mid-2025 catalysts for EYLEA HD, including the prefilled syringe launch and label ...

The CRL did not identify any issues with the safety or efficacy of EYLEA HD in its. TARRYTOWN, N.Y., April 18, 2025 (GLOBE ... which is the maximum dosing interval currently indicated in the label).

Regeneron (NASDAQ:REGN) 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 ...

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 ...

Guidance language shifted to highlight mid-2025 catalysts for EYLEA HD, including the prefilled syringe launch and label expansions. In Q3, management only referenced ongoing adoption efforts.

You should not use EYLEA HD or EYLEA if you have an infection in or around the eye, eye pain or redness, or known allergies to any of the ingredients in EYLEA HD or EYLEA, including aflibercept.