News

The delays, first revealed in Regeron’s Q2 report, were chalked up to manufacturing issues at Novo Nordisk-owned plants.
Regeneron Pharmaceuticals ( NASDAQ: REGN) announced that the U.S. FDA has extended the target action dates for two regulatory ...
The hits just keep on coming for Regeneron’s Eylea franchise. | The FDA has extended its target action dates for two ...
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.
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® ...
Moving on, Regeneron’s second-quarter report was largely positive. Total revenues of $3.68 billion (up 4% YoY) beat analyst ...
Regeneron’s shares have dropped sharply since peaking in August 2024, hurt by slowing Eylea sales due to competition from ...
Regeneron Pharmaceuticals, Inc. (REGN) announced on Wednesday that the U.S. Food and Drug Administration (FDA) has extended ...
Pharmaceuticals announced that the Food and Drug Administration has extended the target action dates to Q4 of 2025 for two Eylea ...
Regeneron Pharmaceuticals said issues at a contract manufacturer have resulted in regulatory setbacks for its Eylea HD eye drug and a proposed lymphoma drug. Regeneron on Friday said an expanded ...
Regeneron is having difficulties again with a contract manufacturer, reporting the delay of two FDA regulatory decisions due this month for Eylea.