The complete response letter (CRL) specifies that the current dosage duration of aflibercept is still safe but extending the ...

The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up ...

In this expert perspective, Manjot K. Gill, MD, discusses the potential FDA approval in 2025 of aflibercept 8 mg for the treatment of retinal vein occlusion.

After 3 initial monthly injections, current dosing intervals range from every 8 to 16 weeks in patients with wAMD and DME and every 8 to 12 weeks in patients with DR.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter ...

The FDA issued a complete response letter for a supplemental biologics license application, in which it did not approve ...

The complete response letter did not identify any issues with the safety or efficacy of Eylea HD, Regeneron officials said.