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.

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

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

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 ...

Patients with diabetic macular edema treated with intravitreal aflibercept have a significantly higher risk of adverse renal events compared with those treated with ranibizumab.

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 ...

Two people in Oregon have died and a third person has a confirmed case of the mad cow-like brain disease Creutzfeldt-Jakob ...

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