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 signs $3 billion deal with FUJIFILM to expand biologics manufacturing in North Carolina, boosting U.S. capacity and ...

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

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

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

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

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

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

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

Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for EYLEA HD Injection 8 mg. The sBLA seeks ...

Regeneron aims for FDA approval of extended dosing for EYLEA HD in AMD and DME, with a decision by April 2025. Pre-filled ...