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Mallinckrodt Pharmaceuticals’ drug becomes the first to snag FDA’s approval for hepatorenal syndrome (HRS)

Terlivaz, Mallinckrodt Pharmaceuticals’ drug for HRS, has received FDA approval, making it the first and only drug to be approved in the US for this disease. HRS is a type of kidney impairment that has no identifiable cause. Though the drug has had approval for treating low blood pressure caused by septic shock and esophageal bleeding in Europe for over 30 years, the company struggled to enter the US. Now the drug has been recommended by the American Association for the Study of Liver Diseases (AASLD) guidance and the guidelines of the American College of Gastroenterology (ACG) as well.

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