priority review

June 25, 2020June 25, 2020

Relugolix Granted FDA Priority Review as New Treatment Type

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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 ... Read more

January 22, 2020May 22, 2020

FDA Grants Priority Review to Lynparza as Treatment for Mutated Metastatic Castration-resistant Prostate Cancer

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Note: This story was updated May 21, 2020, to note that Merck is known as MSD outside the U.S. and Canada, not as EMD Serono. The U.S. Food and Drug Administration ... Read more

January 16, 2020January 16, 2020

Rubraca Granted FDA Priority Review for Advanced Prostate Cancer with BRCA Mutations

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The U.S. Food and Drug Administration (FDA) has granted priority review to Clovis Oncology’s application seeking approval of Rubraca (rucaparib) for treating men with recurrent metastatic castration-resistant prostate cancer (mCRPC) and BRCA mutations. The priority review status ... Read more

January 2, 2018January 2, 2018

FDA Grants Janssen Biotech’s Apalutamide Priority Review Designation to Treat Non-metastatic CRPC

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The U.S. Food and Drug Administration (FDA) has granted priority review status to apalutamide — an investigational androgen receptor inhibitor — to treat men with non-metastatic castration-resistant prostate cancer (CRPC). This ... Read more