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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.
Apr 29, 2026
Three FcRn inhibitors are approved for generalized myasthenia gravis, with a head-to-head trial of efgartigimod and nipocalimab underway. Emerging therapies including telitacicept, gefurulimab, and CAR-T cell therapy (KYV-101) show promise, while Immunovant's batoclimab failed TED trials.
Apr 21, 2026
Regeneron said the Phase 3 NIMBLE trial of cemdisiran in generalized myasthenia gravis met primary and key secondary endpoints at week 24. The company said a U.S. regulatory application has been submitted and EU filings are planned for 2026.
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.
