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.
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Biospace Inc.