News

This was a low-key week for the biotech sector before the onset of the first-quarter earnings season. Biotech giant Bristol ...
Biotech giant Regeneron Pharmaceuticals, Inc. REGN is slated to report first-quarter 2025 results on April 29, 2025. The ...
The FDA has issued a CRL regarding the sBLA for aflibercept 8mg injection for the addition of extended dosing intervals across all approved indications.
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 ...
In this expert perspective, Manjot K. Gill, MD, discusses faricimab for the management of retinal vein occlusion.
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.
The complete response letter did not identify any issues with the safety or efficacy of Eylea HD, Regeneron officials said.
The FDA has sent Regeneron a complete response letter, rejecting its bid to stretch the administration of high-dose Eylea ...
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter ...
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 ...
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 ...