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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® ...
Regeneron’s shares have dropped sharply since peaking in August 2024, hurt by slowing Eylea sales due to competition from ...
20h
Asianet Newsable on MSNRegeneron Says FDA Will Take More Time to Review Its Two Eylea HD Submissions
Regeneron Pharmaceuticals, Inc. (REGN) announced on Wednesday that the U.S. Food and Drug Administration (FDA) has extended ...
21h
TipRanks on MSNRegeneron says FDA delayed review of two Eylea HD submissions
Pharmaceuticals announced that the Food and Drug Administration has extended the target action dates to Q4 of 2025 for two Eylea ...
Opthea’s options may be shrinking as the eye disease biotech comes to terms with a pair of phase 3 failures, but the company ...
After an unusual first quarter in which seven of the biopharma industry’s | Several U.S. pharma companies that had posted ...
China’s RemeGen has sold certain Asia rights to its phase 3-stage eye disease drug to Japan’s Santen Pharmaceutical for 250 ...
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