Michael Makris: NovoNordisk Has Applied to the FDA for Approval of Mim8
Sep 29, 2025, 21:11

Michael Makris: NovoNordisk Has Applied to the FDA for Approval of Mim8

Michael Makris, Emeritus Professor of Haemostasis and Thrombosis at the University of Sheffield, UK. Editor-in-Chief of Research and Practice in Thrombosis and Haemostasis, shared on LinkedIn:

‘NovoNordisk has applied to the FDA for approval of Mim8, a bispecific antibody which will be a direct competitor to emicizumab (Hemlibra).

The data we have seen presented at scientific meetings and published are strong, and suggest that approval is likely to be given.”

Read the full article here.

Article: Novo Nordisk submits Biologics License Application (BLA) to FDA for Mim8; an investigational, prophylaxis treatment for people living with hemophilia A with or without inhibitors

Michael Makris: NovoNordisk Has Applied to the FDA for Approval of Mim8

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