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Ariad Unfazed By FDA Breakthrough Denial

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA denied a “breakthrough” designation request for ALK/EGFR inhibitor AP26113, but the door is open for another try, and the undaunted company is launching a pivotal trial in NSCLC this quarter. Ariad also reported a continued successful launch of its leukemia drug Iclusig.

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