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FDA raises PML concerns with Takeda's colitis, Crohn's drug vedolizumab

This article was originally published in Scrip

Executive Summary

US FDA drug reviewers on 5 December questioned whether the risks of a rare, serious, progressive neurologic disease, known as progressive multifocal leukoencephalopathy (PML), outweigh the benefits of Takeda's experimental drug vedolizumab in treating moderately to severely active ulcerative colitis (UC) and as a therapy for active Crohn's disease.



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