Relugolix Granted FDA Priority Review as New Treatment Type

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Relugolix Granted FDA Priority Review as New Treatment Type
June 26, 2020June 26, 2020
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The U.S. Food and Drug Administration (FDA) has granted priority review to the new drug application (NDA) Myovant Sciences submitted earlier this year requesting the approval of relugolix for the treatment of men with advanced prostate cancer. The priority review status will shorten relugolix’s regulatory review for this indication from the standard 10 months to six months. The FDA has set a prescription drug user fee act (PDUFA) action date for Dec. 20. That means…

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