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 ...
Regeneron investors should embrace the fact that Eylea is no longer a growth product and focus on the rest of the commercial ...
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 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 ...
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 ...
Regeneron Pharmaceuticals recently saw its Fair Value price target increased from $722.20 to $735.72. This change comes on ...
TARRYTOWN, N.Y., April 29, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (REGN) today announced the presentation of positive long-term results and subgroup analyses from the pivotal ...
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 ...
(RTTNews) - Regeneron Pharmaceuticals Inc. (REGN) announced positive three-year (156-week) results for EYLEA HD (aflibercept) Injection 8 mg in patients with wet age-related macular degeneration or ...
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