The delays, first revealed in Regeron’s Q2 report, were chalked up to manufacturing issues at Novo Nordisk-owned plants.

The hits just keep on coming for Regeneron’s Eylea franchise. | The FDA has extended its target action dates for two ...

Regeneron Pharmaceuticals (NASDAQ:REGN) announced that the U.S. FDA has extended the target action dates for two regulatory ...

Before Novo arrived as its owner, issues at the Bloomington facility caused a two-month delay for Eylea HD’s FDA approval decision in 2023. In November 2024, the FDA also found quality control lapses ...

Regeneron Pharmaceuticals, Inc. (REGN) announced on Wednesday that the U.S. Food and Drug Administration (FDA) has extended ...

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates to the fourth quarter of 2025 for two EYLEA HD® ...

Inspection at Novo Nordisk unit Catalent delays action to Q4 2025, but investors keep faith in Eylea's outlook.

Moving on, Regeneron’s second-quarter report was largely positive. Total revenues of $3.68 billion (up 4% YoY) beat analyst ...

Regeneron's Eylea is competing with Roche's Vabysmo in the ophthalmology market, and it could be vulnerable to biosimilars beginning in 2027 and Medicare negotiations in 2028.

Regeneron (REGN) stock in focus as the company surpasses Street's Q2 projections with strong growth in high-dose Eylea, Dupixent, and Libtayo sales. Read more here.

A quicker-than-expected U.S. approval for Regeneron Pharmaceuticals' high-dose eye disease drug, Eylea, should help return the blockbuster treatment back to growth in the next few years, Wall ...