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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 ...
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 ...
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 ...
High-dose aflibercept offers extended dosing intervals for DME and wet AMD, with sustained visual and anatomical improvements. The PULSAR and PHOTON trials showed efficacy in maintaining vision ...
(Vogue) The FDA declined to approve a new dosing schedule for aflibercept 8 mg (Eylea HD), for its approved indications, drugmaker Regeneron Pharmaceuticals announced. The agency also broadcast an ...
The complete response letter did not identify any issues with the safety or efficacy of Eylea HD, Regeneron officials said. The FDA has issued a complete response letter (CRL) for the supplemental ...
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 extended ...
CSU is stated to be a chronic inflammatory skin condition leading to recurring itch and severe hives. Credit: Andrey_Popov/Shutterstock. Sanofi and Regeneron’s ...
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 ...
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