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Niraparib Approval Status

Niraparib is an oral, poly ADP-ribose polymerase (PARP) inhibitor in development for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

Development Status and FDA Approval Process for niraparib

DateArticle
Nov  1, 2016Tesaro Announces Submission of Niraparib NDA For Platinum-sensitive, Recurrent Ovarian Cancer
Sep 12, 2016Tesaro Receives FDA Fast Track Designation for Niraparib and Initiates Rolling NDA Submission
Jun  4, 2013Tesaro and the European Network of Gynecological Oncological Trial Groups Forge Partnership to Develop Niraparib for Ovarian Cancer
Jun  4, 2013TESARO Details Niraparib Phase 1 Clinical Data Presented at the 2013 ASCO Annual Meeting

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