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

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.

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

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

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

The FDA has sent Regeneron a complete response letter, rejecting its bid to stretch the administration of high-dose Eylea ...

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

Pharmaceuticals announced on Friday the Food and Drug Administration has issued a complete response letter regarding the ...

In patients with active cancer and venous thromboembolism, whether extended treatment with a reduced dose of an oral anticoagulant is effective in preventing recurrent thromboembolic events 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 ...