FDA Rejects Regeneron's Eylea HD
Regeneron plans to re-apply to the FDA with a new pre-filled syringe manufacturing filler in January 2026.
The US Food and Drug Administration (FDA) rejected a prefilled syringe version of Regeneron's Eylea HD due to manufacturing issues.
- The FDA issued a complete response letter for Eylea HD's pre-filled syringe supplemental biologics licence application.
- Unresolved issues at Novo Nordisk's filling plant in Bloomington, Indiana, were the sole reason for the rejection.
The FDA uncovered problems during an inspection of Novo Nordisk's filling plant, reported by Regeneron in August 2025.
Author's summary: FDA rejects Eylea HD due to manufacturing issues.
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