Business · 26/03/2024

FDA Withdraws Approval of PARP Inhibitor Indications for Advanced Ovarian Cancer

The FDA is withdrawing approval of the indications for treating adult patients with advanced ovarian cancer for poly (ADP-ribose) polymerase inhibitors, including Rucaparib, Olaparib, and Niraparib, from applicants Clovis Oncology, Inc., AstraZeneca Pharmaceuticals LP, and GlaxoSmithKline LLC.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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