Eylea HD
FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues
FDA delay; Regeneron; Eylea HD; manufacturing issues; Novo Nordisk facility; biosimilars; pre-filled syringe; macular oedema; retinal vein occlusion; regulatory approval
Regeneron Faces Another FDA CRL for Eylea HD, Predicts August PDUFA Delay
Regeneron; Eylea HD; CRL; FDA; PDUFA; supplemental Biologics License Application; dosing intervals; retinal diseases
FDA rejection of extended dosing interval is another piece of bad news for Regenerons Eylea HD
United States Food and Drug Administration, Interval, Regeneron, dosing, Extension, Eylea HD, rejection, Age related macular degeneration, Diabetic Retinopathy
Regeneron and Bayer Achieve Phase III Success with High-Dose Eylea for Retinal Vein Occlusion, Paving Way for Label Expansion
Regeneron, Bayer, Eylea HD, Retinal Vein Occlusion (RVO), Macular Edema, Phase III Trial, Label Expansion, Biosimilar Competition