GlaxoSmithKline’s Malaria Drug Wins FDA “Breakthrough” Status

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GlaxoSmithKline (GSK) and Medicines for Malaria Venture (MMV) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for tafenoquine, an investigational medicine for the treatment and relapse prevention of Plasmodium vivax malaria. Tafenoquine is not yet approved or licensed for use anywhere in the world. Breakthrough Therapy designation is the newest of the FDA’s programs aimed at accelerating the development and review times of drugs for serious or life-threatening conditions.

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