Johnson & Johnson has submitted a Biologics License Application (BLA) to the FDA seeking approval for nipocalimab, an investigational treatment for generalized myasthenia gravis (gMG). This would mark the first FDA approval for nipocalimab globally. The application is based on positive results from the Phase 3 Vivacity-MG3 study, which showed that nipocalimab plus standard of care was superior to placebo plus standard of care in a broad population of antibody-positive gMG patients.