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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 delays, first revealed in Regeneron’s Q2 report, were chalked up to manufacturing issues at Novo Nordisk-owned plants.
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Pharmaceutical Technology on MSNNovo’s facility issues delay FDA decisions on Regeneron’s Eylea HD
Before Novo arrived as its owner, issues at the Bloomington facility caused a two-month delay for Eylea HD’s FDA approval ...
Regeneron Pharmaceuticals announced FDA extended review timelines to Q4 2025 for two regulatory submissions related to Eylea ...
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.
Despite boasting a new owner, the Indiana manufacturing plant that Novo Nordisk picked up as part of its parent company's ...
Moving on, Regeneron’s second-quarter report was largely positive. Total revenues of $3.68 billion (up 4% YoY) beat analyst ...
The Regeneron litigation highlights that donations routed through independent entities are not immune from challenge, especially if the government believes they are effectively covering a patient’s co ...
Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application Apr. 18, 2025 3:00 PM ET Regeneron Pharmaceuticals, Inc. (REGN) ...
Regeneron's first-quarter results missed Wall Street estimates on Tuesday due to stiff competition for its blockbuster drug Eylea, further stoking investor worries as U.S. regulators denied ...
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