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Merck's Supplemental New Drug Application for Welireg Granted Priority Review by FDA

MT Newswires Live01-27

Merck (MRK) said Monday that the US Food and Drug Administration has granted priority review to the supplemental new drug application for Welireg, also known as belzutifan, as a treatment for adult and pediatric patients with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.

The company said the application was based on the objective response rate and duration of response data from a phase 2 trial of Welireg, which will be presented at an upcoming medical meeting.

According to Merck, the FDA has set a target action date of May 26 for the application.

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  • BoonHuat
    ·01-27
    Nice
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