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

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 ...

Workers at INCOG Biopharma in Fishers inspect up to 1,000 syringes a day, looking for bent needles, cracked glass or particles in the medicine. The company is a behind-the-scenes player in the ...

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

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 ...