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

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

The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application ...

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 ...

The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application ...

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.

EYLEA HD ® (aflibercept) Injection 8 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), 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 ...

Biotech giant Regeneron Pharmaceuticals, Inc. REGN is slated to report first-quarter 2025 results on April 29, 2025. The ...

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

DME and DR. EYLEA HD (known as Eylea™ 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG. Regeneron maintains exclusive rights to EYLEA and EYLEA HD in ...

The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ supplemental biologics licence application (sBLA) for Eylea HD (aflibercept) injection 8mg for priority review.