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InfaCare’s Jaundice Drug Stannsoporfin Brings Efficacy, Safety Questions Into US FDA Panel

Executive Summary

Whether the single pivotal trial provides ‘substantial and highly persuasive evidence of effectiveness’ is a key question for advisory committee, although FDA also seeks advice on adequacy of the data to characterize adverse neurodevelopment outcomes; if approved, the heme oxygenase inhibitor could face a restrictive Risk Evaluation and Mitigation Strategy.

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