Retinal Vein Occlusion

FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues

3 weeks ago talkbio0Tagged Biosimilars, Deferred, Edema, Eylea HD, macular, manufacturing issues, Nordisk facility, Pre-filled Syringe, Regeneron, regulatory approval, Retinal Vein Occlusion, United States Food and Drug Administration

FDA delay; Regeneron; Eylea HD; manufacturing issues; Novo Nordisk facility; biosimilars; pre-filled syringe; macular oedema; retinal vein occlusion; regulatory approval

Regeneron’s EYLEA HD Succeeds in Phase 3 Trial for Retinal Vein Occlusion, Paving Way for 2025 FDA Submission

9 months ago talkbio0Tagged aflibercept, dosing, Extension, Eylea, Hodgkin Disease, Interval, Phase 3 QUASAR trial, Regeneron, Retinal Vein Occlusion, Submission, United States Food and Drug Administration

EYLEA HD, Aflibercept, Retinal Vein Occlusion (RVO), Phase 3 QUASAR Trial, Extended Dosing Intervals, FDA Submission 2025, Regeneron Pharmaceuticals

Regeneron and Bayer Achieve Phase III Success with High-Dose Eylea for Retinal Vein Occlusion, Paving Way for Label Expansion

9 months ago talkbio0Tagged Bayer, Biosimilars, competition, expansion, Eylea HD, Macular retinal edema, Phase 3 Clinical Trials, Regeneron, Retinal Vein Occlusion

Regeneron, Bayer, Eylea HD, Retinal Vein Occlusion (RVO), Macular Edema, Phase III Trial, Label Expansion, Biosimilar Competition

FDA Grants Approval for First Interchangeable Biosimilars to Regeneron’s Eylea

1 year ago talkbio0Tagged Approved, Biosimilars, blockbuster, Diabetic Retinopathy, interchangeable, Macular degeneration, Regeneron, Retinal Vein Occlusion, United States Food and Drug Administration

FDA, biosimilars, interchangeable, Regeneron, Eylea, approval, blockbuster, drug, treatment, eye diseases, macular degeneration, diabetic retinopathy, retinal vein occlusion