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FDA Expands Efgartigimod Approval to All Adult Generalized Myasthenia Gravis Patients

May 10, 2026

The FDA expanded efgartigimod approval to all adult generalized myasthenia gravis serotypes. Phase 3 ADAPT SERON met its primary endpoint and showed no new safety signals.

Amgen's Uplizna Wins FDA and European Approval for Generalized Myasthenia Gravis

Dec 11, 2025

Amgen received FDA and European Commission approval for Uplizna to treat generalized myasthenia gravis in adults who are anti-AChR or anti-MuSK antibody positive, offering twice-yearly maintenance dosing after initial loading doses.