Regeneron Pharmaceuticals (NASDAQ:REGN) said on Thursday that the U.S. FDA will be reviewing the supplemental biologics license application ((sBLA)) for Eylea HD injection, 8 mg, to treat macular ...

Regeneron's first-quarter results missed Wall Street estimates on Tuesday due to stiff competition for its blockbuster drug ...

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 ...

While Regeneron remains confident that Eylea HD sales will continue to grow over time, copay problems and off-label Avastin use ... and the supplier has told us that the FDA asked for some data.” ...

which is the maximum dosing interval currently indicated in the label). Nonetheless, the FDA accepted the sBLA for Eylea HD injection 8 mg. The sBLA seeks approval for Eylea HD to treat macular ...

Regeneron books full US Eylea sales, and 80% of its Eylea-related ... costs related to product governance ESG risks (such as off-label marketing or litigation related to side effects), and model ...

As the first-to-file interchangeable biosimilar to Eylea, Yesafili affirms our scientific strength and marks our strategic entry into ophthalmology, expanding our footprint in the US and advancing our ...

Regulatory delays impacting EYLEA HD’s pre-filled syringe approval could hinder adoption. Increased market share of off-label Avastin poses a challenge to the anti-VEGF category. Analysts raised ...

Total revenues decreased 4% year over year to $3 billion due to lower sales of lead drug Eylea. Revenues also missed the Zacks Consensus Estimate of $3.27 billion. Sales of oncology drug ...