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Pharmaceutical Technology11h

Novo’s facility issues delay FDA decisions on Regeneron’s Eylea HD

T. Schneider via Shutterstock.com. The US Food and Drug Administration (FDA) has delayed decisions on two regulatory ...

FDA Pushes Back Eylea HD Review; Regeneron Still Gains

Inspection at Novo Nordisk unit Catalent delays action to Q4 2025, but investors keep faith in Eylea's outlook.
Fierce Pharma16h

FDA delays 2 decisions on Regeneron's Eylea HD because of manufacturing issues

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

Regeneron's Eylea injection review dates delayed by FDA

Regeneron Pharmaceuticals ( NASDAQ: REGN) announced that the U.S. FDA has extended the target action dates for two regulatory ...
Pharmaceutical Commerce18h

Catalent to Lay Off 350 Workers at Baltimore Gene Therapy Plant

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.
Asianet Newsable on MSN18h

Regeneron 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 ...

EYLEA HD® (aflibercept) Injection 8 mg Applications for Expanded U.S. Label and Prefilled Syringe Receive FDA Review Period Extension

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® ...
TipRanks on MSN19h

Regeneron 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 ...