The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet virtually on Wednesday, July 15, to review and discuss Mallinckrodt’s (MNK +12.1%) marketing application seeking approval to use terlipressin to treat hepatorenal syndrome type 1 (HRS-1), a type of progressive kidney failure in patients with severe liver damage, typically from cirrhosis.
Based on the agency’ briefing document, it looks promising for a positive vote backing approval.
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