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 at Novo Nordisk's facility.
- Reason for rejection: unresolved issues at Novo Nordisk's filling plant in Bloomington, Indiana.
- FDA inspection in August 2025 uncovered problems at the facility.
The sole reason for the rejection was unresolved issues at a facility of its manufacturing partner, Novo Nordisk.
Author's summary: FDA rejects Regeneron's Eylea HD due to manufacturing issues.