FDA Accepts Supplementary PMA for Review of BRACAnalysis CDx as a Companion Diagnostic to Talazoparib in Metastatic Breast Cancer

June 27, 2018 – The U.S. Food and Drug Administration (FDA) recently accepted a supplementary premarket approval (PMA) application for BRACAnalysis CDx to be used as a companion diagnostic with the poly ADP ribose polymerase (PARP) inhibitor talazoparib. The new drug application (NDA) for talazoparib has been granted Priority Review by the FDA and has a Prescription Drug User Fee Act goal date of December 2018. The supplementary PMA and NDA submissions are … (leggi tutto)