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 Pharmaceuticals beat Wall Street estimates for third-quarter results on Tuesday, helped by strong demand for its ...
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.
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 ...
Discover why Regeneron Pharmaceuticals, Inc.'s Q3 earnings impress, fueled by Dupixent growth and a robust pipeline. Click ...
Regeneron has once again received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for the ...
Regeneron posts Q3 earnings of $11.83 per share, topping estimates as Dupixent profits lift results despite weaker Eylea ...
Regeneron investors should embrace the fact that Eylea is no longer a growth product and focus on the rest of the commercial ...
Regeneron has settled its patent dispute with Celltrion, giving the go-ahead for another biosimilar to its blockbuster eye drug Eylea (aflibercept) to hit the U.S. market in just over a year. | With ...
Regeneron Pharmaceuticals recently saw its Fair Value price target increased from $722.20 to $735.72. This change comes on ...
Otsuka Pharmaceuticals could shell out over $400 million in total for the Asia-Pacific rights to 4D-150, which combines a ...
Regeneron Pharmaceuticals beat Wall Street estimates for third-quarter results on Tuesday, helped by strong demand for its ...
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