Johnson & Johnson announced the nipocalimab Biologics License Application received Priority Review designation from the U.S Food and Drug Administration for the treatment of antibody positive patients with generalized myasthenia gravis, as supported by findings from the Phase 3 Vivacity-MG3 study. “The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications,” the company stated.
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