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3 years ago

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FDA rejects Mallinckrodt's kidney drug over risk-benefit doubts

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FDA rejects Mallinckrodt's kidney drug over risk-benefit doubts

The FDA has rejected Mallinckrodt's request for approval of terlipressin in a rare type of progressive kidney failure. Mallinckrodt suffered the setback despite hitting its primary endpoint in phase 3 and winning the backing of an advisory committee in a split decision.

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FDA rejects Mallinckrodt's kidney drug over risk-benefit doubts

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FDA rejects Mallinckrodt's kidney drug over risk-benefit doubts

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