The FDA has approved Imaavy™ (nipocalimab-aahu) for the treatment of generalized myasthenia gravis in patients aged 12 years and older who are AChR or anti-muscle-specific tyrosine kinase antibody ...

The FDA's decision followed results from the ongoing Phase III Vivacity-MG3 trial, which evaluates IMAAVY in combination with standard care versus placebo and standard care in 199 adult gMG ...

The results from the Vivacity-MG3 study, presented at the European Academy of Neurology (EAN), show an improvement with nipocalimab compared to placebo on activities of daily living scores that ...

The FDA's decision followed results from the ongoing Phase III Vivacity-MG3 trial, which evaluates IMAAVY in combination with standard care versus placebo and standard care in 199 adult gMG ...

The filing is based on the results of the Vivacity-MG3 study, which showed an improvement with nipocalimab compared to placebo on activities of daily living scores that J&J says have not been seen ...

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 gMG, including those ...

was approved for patients 12 years and older with generalized myasthenia gravis based on data from the ongoing Vivacity-MG3 study. Research presented at the recent annual meeting of the Academy of ...

today announced results from additional analyses of the Phase 3 Vivacity-MG3 double-blind study and the ongoing open-label extensiona (OLE), evaluating the long-term efficacy and safety of ...