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FDA Panel Gives Thumbs Up To Higher Dose Of Bayer’s Riociguat

This article was originally published in The Pink Sheet Daily

Executive Summary

Committee favors sponsor’s proposed maximum dose of 2.5 mg three times daily over FDA’s recommendation for a 1.5 mg dose but generally agrees with agency’s call for a lower starting dose; panel unanimously backs approval of the novel vasodilator for two pulmonary arterial hypertension indications.

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