Nasdaq

EU Approves Bayer's Eylea 8 Mg For Extended 6-Month Dosing In Retinal Diseases

(RTTNews) - Bayer (BAYZF.PK, BAYRY.PK, BYR.L), a German pharmaceutical and life sciences major, announced that the European Commission has granted a label extension in the European Union for Eylea 8 ...
Seeking Alpha

EYLEA HD® (aflibercept) Injection 8 mg Approved by FDA for the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing Across Approved Indications

TARRYTOWN, N.Y., Nov. 19, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA HD ® (aflibercept) ...
Reuters

Bayer wins EU watchdog's endorsement for longer Eylea treatment intervals

May 23 (Reuters) - German drugmaker Bayer (BAYGn.DE), opens new tab on Friday won an endorsement by the European Medicines Agency to extend the intervals between shots of its anti-blindness treatment ...
Seeking Alpha

EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly ...

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 – halving the number of injections that are indicated ...
WKRG

EYLEA HD (aflibercept) Injection 8 mg Approved by FDA for Treatment of Wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR)

Approval based on the pivotal PULSAR and PHOTON trials in which EYLEA ® HD demonstrated clinically equivalent vision gains to EYLEA (aflibercept) Injection 2 mg that were maintained with fewer ...
ksn.com

EYLEA® HD (aflibercept) Injection 8 mg Pivotal Data in Wet Age-related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME) Published in The Lancet

TARRYTOWN, N.Y., March 08, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced The Lancet published one-year results from the pivotal PULSAR and PHOTON trials for ...
Nasdaq

Regeneron Announces FDA Acceptance of Priority Review for EYLEA HD® Supplemental Application for Retinal Vein Occlusion Treatment

Regeneron Pharmaceuticals has announced the U.S. FDA's acceptance for Priority Review of the supplemental Biologics License Application for EYLEA HD (aflibercept) Injection 8 mg, which, if approved, ...
ksn.com

Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application

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 ...