US FDA rejection of Repligen pancreatic MRI agent confirmed
This article was originally published in Scrip
Executive Summary
Repligen confirmed on 22 June that it did indeed receive a complete response letter (CRL) from the US FDA for the firm's new drug application (NDA) for RG1068, a synthetic version of human secretin, as an agent to detect pancreatic duct abnormalities in combination with MRI in patients with pancreatitis.