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GSK Moves Closer To Priority Review Voucher As US Panel Backs Malaria Drug Tafenoquine

Executive Summary

GlaxoSmithKline's user fee date is July 22, four days before advisory committee review of 60 Degrees’ separate application for the compound.

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Postmarketing studies are needed to assess tafenoquine’s efficacy in children, older adults and heavier individuals, and to answer questions about psychiatric safety and other adverse events, advisory committee says.

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