Johnson & Johnson (JNJ) announced that the FDA has accepted its regulatory filing seeking the FDA's approval for nipocalimab, its investigational neonatal Fc receptor (FcRn) blocker, in generalized myasthenia gravis (gMG) indication. The filing has been granted priority review by the FDA, bringing down the review period by four months. We expect a final decision in the third quarter of 2025. The FDA filing is supported by data from the phase III Vivacity-MG3 study, which evaluated nipocalimab in adults with ...