The FDA has recently expanded the approval of Soliris, a medication for patients with generalized myasthenia gravis (gMG), to include children aged 6 and older. This is significant because Soliris, which is an intravenous monoclonal antibody, is now the first and only treatment option for this younger demographic with gMG who test positive for anti-acetylcholine receptor antibodies. The Muscular Dystrophy Association has highlighted this approval, which was previously limited to adults with the same condition. This expansion offers new hope for younger patients and their families, as it provides a targeted treatment option for managing this neuromuscular disease (Herpen & MA, 2025). The approval of Soliris for this new age group is a milestone in the treatment of gMG, as it addresses a previously unmet medical need. The decision by the FDA was based on clinical data that demonstrated the safety and efficacy of Soliris in younger patients. This development is particularly important because it opens the door to improved quality of life and better disease management for children suffering from gMG, offering them a treatment that was once only available to adults.
Clinical Trials
This is a list of upcoming or ongoing clinical trials that are actively recruiting and have been listed or updated in the last two weeks:
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