The FDA has granted Priority Review to nipocalimab for the treatment of antibody positive patients with generalized myasthenia gravis.

In part 2 of our interview with Katie Abouzahr, MD, Johnson & Johnson Innovative Medicine, we discuss the challenge inherent ...

The US Food and Drug Administration (FDA) has awarded the second breakthrough therapy designation (BTD) to Johnson & Johnson's (J&J) nipocalimab for treating individuals with moderate-to-severe ...

Johnson & Johnson’s ‘Swiss army knife’ for autoimmune diseases – FcRn inhibitor nipocalimab – has shown efficacy in Sjogren’s disease (SjD), an autoimmune condition that affects ...

Johnson & Johnson announced The Lancet Neurology has published results from the pivotal Phase 3 study of nipocalimab, an investigational ...

Jan. 9, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the nipocalimab Biologics License Application (BLA) received Priority Review designation from the U.S Food and Drug ...

Johnson & Johnson has submitted its first marketing application for nipocalimab, seeking approval for the FcRn blocker in generalised myasthenia gravis (gMG), where it would compete with rivals in ...

Findings showed nipocalimab plus standard of care (SOC) improved MG-ADL score from baseline by 4.70 points compared with 3.25 points with placebo plus SOC over weeks 22, 23, and 24. The Food and ...