Bayer has overturned a ruling that it brought discredit on the pharma industry. | Bayer has overturned a ruling that it ...

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

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

EYLEA ® (aflibercept) Injection 2 mg is a prescription medicine approved for the treatment of patients with Wet Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion ...

Operating expenses have also likely increased in the quarter due to pipeline advancement and higher commercialization-related expenses to support the launch of Eylea HD and higher headcount ...

The company has several marketed products, including low-dose Eylea and Eylea HD, approved for wet age-related macular degeneration and other eye diseases; Dupixent in immunology; Praluent for LDL ...

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 ...

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 ...

EYLEA HD is approved with dosing intervals from ... and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s ...