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FDA issues CRL for Regeneron's aflibercept 8 mg (Eylea HD) sBLA
FDA issues CRL for Regeneron's aflibercept 8 mg (Eylea HD) sBLA

April 21st 2025

The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up to 24 weeks across currently-approved indications.

FDA accepts Regeneron's sBLA for Eylea HD as priority review
FDA accepts Regeneron's sBLA for Eylea HD as priority review

April 17th 2025

Aflibercept: Applications for dosing duration and additional indications pending decision with FDA and EMA
Aflibercept: Applications for dosing duration and additional indications pending decision with FDA and EMA

April 16th 2025

Biocon, Regeneron settle to launch aflibercept biosimilar, Yesafili in the US
Biocon, Regeneron settle to launch aflibercept biosimilar, Yesafili in the US

April 15th 2025

Healthy lifestyles translate to lower risk of retinal disease
Healthy lifestyles translate to lower risk of retinal disease

February 14th 2025

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