The FDA has sent Regeneron a complete response letter, rejecting its bid to stretch the administration of high-dose Eylea ...

The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up ...

Pharmaceuticals announced on Friday the Food and Drug Administration has issued a complete response letter regarding the ...

The complete response letter did not identify any issues with the safety or efficacy of Eylea HD, Regeneron officials said.

Oppenheimer keeps an Outperform rating on Regeneron (REGN) with a $925 price target after the FDA denied the company’s attempt to extend the ...

The FDA issued a complete response letter for a supplemental biologics license application, in which it did not approve ...

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept injection 8mg for the treatment of macular edema following ...

Investors' focus is likely to be on the performance of Dupixent and the uptake of Eylea HD when REGN reports first-quarter results on April 29.

The sBLA seeks approval for Eylea HD for both the treatment of macular edema following retinal vein occlusion and broadening ...

Regeneron's oncology platform is poised to be a significant growth driver in the next decade. Read why REGN stock remains a ...

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 ...

Regeneron Pharmaceuticals (NASDAQ:REGN) said on Thursday that the U.S. FDA will be reviewing the supplemental biologics ...