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FDA Starts Its Second Safety Investigation Into Novartis/Orion's Parkinson's Drug Stalevo

This article was originally published in The Pink Sheet Daily

Executive Summary

An FDA meta-analysis reveals a cardiovascular safety risk with Orion and Novartis' Stalevo, on top of an ongoing review of a prostate cancer imbalance, but uncertainty about the data raises the question of whether FDA will want a prospective heart safety study.

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