The FDA has accepted for Priority Review the sBLA for aflibercept injection 8mg for the treatment of macular edema following RVO and for monthly dosing in approved indications.

Apremilast treatment in patients with psoriatic arthritis leads to favorable changes in body composition and improves disease ...

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 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 ...

EYLEA ® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion ...

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

Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo In the U.S., there are more than ...

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