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Kynamro Liver Safety Data Faces FDA Advisory Committee Gauntlet

This article was originally published in The Pink Sheet Daily

Executive Summary

Questions about liver toxicity have dogged Genzyme/Isis’ Kynamro (mipomersen), despite robust LDL-lowering. An FDA panel review in October will tell whether seemingly reassuring safety data from a long-term extension study will do the trick for U.S. approval.

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