Pharmaceutical Technology on MSN
FDA rejects Regeneron’s pre-filled Eylea HD syringes amid filling facility woes
Regeneron is planning to re-apply to the FDA with a new pre-filled syringe manufacturing filler in January 2026.
Regeneron Pharmaceuticals beat Wall Street estimates for third-quarter results on Tuesday, helped by strong demand for its ...
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 ...
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 investors should embrace the fact that Eylea is no longer a growth product and focus on the rest of the commercial ...
Regeneron posts Q3 earnings of $11.83 per share, topping estimates as Dupixent profits lift results despite weaker Eylea ...
Regeneron has once again received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for the ...
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 ...
Third quarter 2025 revenues increased 1% to $3.75 billion versus third quarter 2024Dupixent® global net sales (recorded by Sanofi) increased 27% to $4.86 billion EYLEA HD® U.S. net sales increased 10% ...
Regeneron Pharmaceuticals recently saw its Fair Value price target increased from $722.20 to $735.72. This change comes on ...
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 ...
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 ...
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