Delcath slips on FDA delay for drug/device Melblez Kit
This article was originally published in Scrip
Executive Summary
Shares of Delcath Systems took a 6.8% hit on 8 April after the US FDA delayed by three months the Prescription Drug User Fee Act (PDUFA) action date for the company's new drug application (NDA) Melblez Kit (melphalan), a drug/device injectable combination treatment for patients with unresectable ocular melanoma metastatic to the liver.