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FDA Goes To Committee With Uncertainty About Metreleptin Efficacy For Partial Lipodystrophy

This article was originally published in The Pink Sheet Daily

Executive Summary

The Dec. 11 Endocrinologic and Metabolic Drugs Advisory Committee also will consider whether a proposed Risk Evaluation and Mitigation Strategy would address the possible risk for lymphoma and immunogenicity with Bristol-Myers Squibb/AstraZeneca’s drug.

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Metreleptin Needs Tighter Partial Lipodystrophy Indication, Panel Says

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