News

Managed Healthcare Executive3d
FDA Sets Action Date for Eylea HD in Retinal Vein Occlusion
If approved, Eylea would be the first treatment for RVO with 8-week dosing. The FDA target action date is Aug. 19, 2025.
MPR3d
High Dose Aflibercept Gets Priority Review for Retinal Vein Occlusion and Monthly Dosing
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept injection 8mg for the treatment of macular edema following ...
FDA to review Regeneron’s sBLA for aflibercept injection 8mg
The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application ...
Ophthalmology Times3d
Regeneron’s sBLA for Eylea HD accepted for priority review by FDA
The sBLA seeks approval for Eylea HD for both the treatment of macular edema following retinal vein occlusion, and for ...
Ophthalmology Times4d
Aflibercept: Applications for dosing duration and additional indications pending decision with FDA and EMA
Regeneron aims for FDA approval of extended dosing for EYLEA HD in AMD and DME, with a decision by April 2025. Pre-filled ...
Biocon Biologics Ltd.: Biocon Biologics Secures Market Entry Date for Yesafili, an Interchangeable Biosimilar to Eylea, in the U.S.
BRIDGEWATER, N.J. and BENGALURU, Karnataka, India, April 15, 2025 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon ...
Le Lézard5d
Biocon Biologics Secures Market Entry Date for Yesafilitm, an Interchangeable Biosimilar to Eylea®, in the U.S.
Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced today a settlement and license agreement with ...
Biocon subsidiary secures permission to launch eye medicine Yesafili in US
This agreement enables the company to launch in the US in the second half of calendar year 2026 or earlier in certain circumstances ...
Biocon Biologics inks a settlement and license agreement with Regeneron
Biocon Biologics and Regeneron executed the settlement agreement to dismiss the pending appeal at the United States Court of Appeals for the Federal Circuit (USCAFC) of patent US11084865 ('865 patent) ...