Nipocalimab granted US FDA priority review for the treatment of generalized myasthenia gravis

Johnson & Johnson

9 January 2024 - Biologics license application acceptance supported by results from the Phase 3 Vivacity-MG3 study.

Johnson & Johnson today announced the nipocalimab biologics license application received priority review designation from the US FDA for the treatment of antibody positive patients with generalised myasthenia gravis, as supported by findings from the Phase 3 Vivacity-MG3 study.

Read Johnson & Johnson press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier