Regeneron Pharmaceuticals (NASDAQ:REGN) said on Thursday that the U.S. FDA will be reviewing the supplemental biologics license application ((sBLA)) for Eylea HD injection, 8 mg, to treat macular ...

Biotech company Regeneron (NASDAQ:REGN) missed Wall Street’s revenue expectations in Q1 CY2025, with sales falling 3.7% year ...

Schleifer attributed the shift to more patients using off-label bevacizumab ... information over to the FDA posthaste following the rejection, Schleifer said. Eylea HD is already approved ...

which is the maximum dosing interval currently indicated in the label). Regeneron is evaluating the FDA’s decision and will determine a path forward in due course. EYLEA HD is approved with ...

Eylea’s sales in the United States plunged ... In April 2025, REGN declared a cash dividend of $0.88 per share. The FDA approved a label expansion of Dupixent for the treatment of adults and ...

Schleifer emphasized the company’s confidence in resolving the FDA issues with the EYLEA HD pre-filled syringe ... Increased market share of off-label Avastin poses a challenge to the anti ...

The FDA target action date is August 19, 2025, following the use of a Priority Review voucher. The sBLA is supported by data from across the EYLEA HD clinical program, including the Phase 3 QUASAR ...

The FDA did not approve the supplemental biologics license application for Eylea HD. The application would have added extended dosing intervals greater than 16 weeks, if approved. Editor’s note ...

Three months later, one of those arrows has missed its target as the FDA has sent Regeneron a complete response letter (CRL), rejecting its bid to stretch the administration of high-dose Eylea ...

Regeneron's first-quarter results missed Wall Street estimates on Tuesday due to stiff competition for its blockbuster drug ...

According to the letter, the FDA did not agree with the proposition ... Additionally, patients who switched from Eylea ® (aflibercept 2mg), the comparator arm, to aflibercept 8mg at the start ...