Mallinckrodt’s Hepatorenal Syndrome Drug Terlipressin Gets A Virtual AdComm
Executive Summary
US FDA cardiovascular and renal drugs panel will weigh approvability of the vasopressin analog during a nine-hour, online meeting 15 July; terlipressin was the focus of a 2009 complete response letter but met its primary endpoint in the recent CONFIRM trial.
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Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.