Generics Bulletin
HBW Insight
In Vivo
Medtech Insight
Pink Sheet
Scrip
Close
Search
Search
Generics Bulletin
HBW Insight
In Vivo
Medtech Insight
Pink Sheet
Scrip
Odronextamab’s Regulatory Journey Highlights Diverging EU and US Requirements
Oct 31 2025
•
By
Manas Mishra
Regeneron's lymphoma product odronextamab was authorized in the EU just months after a US rejection in 2024, followed by a recent complete response letter this year.
(Shutterstock)
More from Pathways & Standards
More from Pink Sheet