Regeneron is planning to re-apply to the FDA with a new pre-filled syringe manufacturing filler in January 2026.

Regeneron Pharmaceuticals, Inc. REGN reported third-quarter 2025 adjusted earnings per share (EPS) of $11.83, which ...

Regeneron has once again received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for the ...

Regeneron investors should embrace the fact that Eylea is no longer a growth product and focus on the rest of the commercial ...

Despite the rejection, analysts saw Regeneron’s use of an alternate filler for Eylea HD as a positive development, with BMO Capital Markets noting that this could signal the end of manufacturing ...

Regeneron Pharmaceuticals beat Wall Street estimates for third-quarter results on Tuesday, helped by strong demand for its ...

The FDA has issued another complete response letter (CRL) to Regeneron, rejecting its bid for approval of its prefilled syringe version of high-dose (HD) Eylea—again for unresolved issues at the ...

Regeneron posts Q3 earnings of $11.83 per share, topping estimates as Dupixent profits lift results despite weaker Eylea ...

Biotech company Regeneron (NASDAQ:REGN) reported Q3 CY2025 results exceeding the market’s revenue expectations, but sales were flat year on year at $3.75 billion. Its non-GAAP profit of $11.83 per ...

A study using AAO's IRIS Registry demonstrates Eylea HD 8 mg improves vision in treatment-naive patients with wet age-related macular degeneration or diabetic macular edema with previously treated ...

Three new post-hoc analyses highlight EYLEA HD rapid and sustained fluid control and consistent safety profile over two years in patients with wet age-related macular degeneration (wAMD) New indirect ...

Approval based on the pivotal PULSAR and PHOTON trials in which EYLEA ® HD demonstrated clinically equivalent vision gains to EYLEA (aflibercept) Injection 2 mg that were maintained with fewer ...