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Regeneron Wins FDA Nod For Eylea HD With Reduced Injection Schedule For Patients With Vision Loss
FDA approves Regeneron's Eylea HD for retinal vein occlusion, adding extended dosing options and greater flexibility across ...
First and only FDA-approved treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period Monthly dosing option in all approved indications provides greater dosing ...
The nods allow Regeneron to better compete with Roche, which stormed the market in 2022 with Vabysmo. The Swiss drugmaker's ...
Pharmaceutical Technology on MSN
Regeneron’s Eylea franchise boosted by pair of FDA approvals
Regeneron has won two US Food and Drug Administration (FDA) approvals for Eylea HD (aflibercept), adding another indication ...
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 ...
The FDA has approved Eylea HD (aflibercept) 8 mg to treat patients with macular edema following retinal vein occlusion (RVO) with dosing of up to every 8 weeks after an initial monthly dosing period.
Supplementary biologics license application planned for submission to the U.S. Food and Drug Administration in the first quarter of 2025 “All currently FDA-approved anti-VEGF therapies for retinal ...
The approvals come as a pleasant surprise for Regeneron, analysts say, helping bolster the overall product profile of ...
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