FDA Extends Review Period of REGN's Submission for Eylea HD

Key Takeaways The FDA extended action dates to Q4 2025 for two Eylea HD regulatory submissions.Extensions followed FDA findings at Catalent Indiana, a Novo Nordisk unit.Eylea HD U.S. sales rose 29% in Q2, even as Eylea continues to decline. Regeneron Pharmaceuticals, Inc. ((REGN) announced that the FDA has extended the target action dates for Eylea HD (aflibercept) injection 8 mg regulatory submissions.Eylea HD is the higher dose of Eylea.The regulatory body has now extended the target action dates to the f ...