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The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8-7 on Wednesday to support approval of Mallinckrodt’s terlipressin for treatment of hepatorenal syndrome type 1 (HRS-1), a life threatening kidney condition in patients with advanced liver disease. Read More
The FDA has handed Mylan and Fujifilm Kyowa Kirin Biologics approval for their biosimilar of Humira (adalimumab), marking the agency’s sixth approval for a biosimilar of AbbVie’s blockbuster immunosuppressive drug. Read More