Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks ...

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

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 ...

The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application ...

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 (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 ...

Yesafili, a vascular endothelial growth factor inhibitor, is used to treat several different types of ophthalmology ...

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 ...

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) ...

Biocon Biologics and Regeneron Pharmaceuticals settled to commercialize aflibercept-jbvf in the US, resolving patent ...

This agreement enables the company to launch in the US in the second half of calendar year 2026 or earlier in certain circumstances ...