Mallinckrodt receives negative response from FDA on New Drug Application (NDA) for terlipressin for treatment of hepatorenal syndrome type 1 (HRS-1)

FDA has requested more data to support positive risk-benefit profile for in patients with HRS-1, an acute & life-threatening syndrome involving acute kidney failure in people with cirrhosis. Company says it remains confident in the strength of the data from phase 3 CONFIRM study.


Biospace Inc.