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The FDA did not approve the supplemental biologics license application for Eylea HD. The application would have added extended dosing intervals greater than 16 weeks, if approved. Editor’s note ...
At the J.P. Morgan Healthcare Conference in January, Regeneron CEO Leonard Schleifer said that the company’s new formulation of eye disease treatment Eylea needed “a few more arrows in its ...
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. Feel unsure about the market ...
“The CRL did not identify any issues with the safety or efficacy of Eylea HD in its approved indications and dosing regimens. The FDA did not agree with Regeneron’s proposal to add additional ...
The CRL did not identify any issues with the safety or efficacy of EYLEA HD in its approved indications and dosing regimens. The FDA did not agree with Regeneron’s proposal to add additional ...
FDA Grants Priority Review to Regeneron’s Eylea for Macular Edema Following Retinal Vein Occlusion
The FDA has granted Priority Review status to Regeneron’s and Bayer’s supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) injection 8 mg. The application seeks to expand use ...
If approved, EYLEA HD would be the first and only treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period, reducing the number of injections by half ...
Oppenheimer keeps an Outperform rating on Regeneron (REGN) with a $925 price target after the FDA denied the company’s attempt to extend the dosing interval in Eylea HD’s label. Extending the ...
Yesafili, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions, is a biosimilar of its reference product Eylea (aflibercept). The ...
A significant chunk of Regeneron’s revenues comes from the sale of its lead drug, Eylea, which is approved for various ophthalmology indications (neovascular age-related macular degeneration ...
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