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

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 ...

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

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 ...

The CDMO will be cutting 350 jobs at its Baltimore gene therapy site after a major client’s demand shift, less than a year after Novo Holdings’ $16.5 billion acquisition.

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® ...

Pharmaceuticals announced that the Food and Drug Administration has extended the target action dates to Q4 of 2025 for two Eylea ...

At the same time, more than half of the US-listed stocks covered by Morningstar that reported earnings as of Aug. 11 beat ...

Regeneron’s shares have dropped sharply since peaking in August 2024, hurt by slowing Eylea sales due to competition from ...

Biotech company Regeneron (NASDAQ:REGN) reported revenue ahead of Wall Street’s expectations in Q2 CY2025, with sales up 3.6% year on year to $3.68 billion. Its non-GAAP profit of $12.89 per share was ...