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

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 ...

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

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

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 ...

Discover Regeneron’s Q3 2025 earnings: strong Dupixent, Libtayo & EYLEA HD growth, R&D updates, plus key manufacturing and regulatory challenges.

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 ...

QUASAR trial showed Eylea HD matched vision gains of standard Eylea with less frequent dosing. BofA cuts Regeneron price target to $547, maintains Underperform rating. Ready to turn the market’s ...