Findings may help with decision-making in this high-risk patient population.
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The updated labeling is based on results from a safety management cohort from the ZUMA-1 study.
Rilzabrutinib is an oral Bruton tyrosine kinase inhibitor currently in development for a number of immune-mediated diseases.
The FDA has approved Zeposia® (ozanimod) for moderately to severely active ulcerative colitis in adults.
In a study, the calcineurin inhibitor tacrolimus proved to be noninferior to intravenous cyclophosphamide.
The approval was based on data from the phase 3 JADE clinical trial program, which included the JADE MONO-1, JADE MONO-2, and JADE COMPARE trials.