The FDA has accepted for Priority Review the sBLA for aflibercept injection 8mg for the treatment of macular edema following RVO and for monthly dosing in approved indications.

Gold dust in eyes might seem like an unusual therapy – but a new mouse study in the US shows the approach could potentially ...

No amount of concealer, color corrector, or undereye patches have been able to reduce the appearance of my fine lines, but ...

The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up ...

The FDA has sent Regeneron a complete response letter, rejecting its bid to stretch the administration of high-dose Eylea ...

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter ...

EYLEA ® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion ...

Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo In the U.S., there are more than ...

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

Regeneron (REGN) announces FDA review of sBLA for Eylea HD to treat macular edema and expand dosing. Read more here.

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

Lined up for the FDA in the coming weeks are a cell-based gene therapy for a rare skin disease and two product expansions for ...