Tags : Metastatic Castration-Resistant Prostate Cancer

Regulatory

Janssen’s Niraparib Receives the US FDA’s Breakthrough Therapy Designation for

Shots: The breakthrough designation is based on P-II GALAHAD study assessing Niraparib in adult patients with BRCA1/2 gene-mCRPC and DNA-repair gene defects (DRD) prior treated with androgen-receptor targeting therapies and docetaxel The FDA’s BT designation is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious […]Read More