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Mallinckrodt Receives A Complete Response Letter From The U.S. FDA For Terlipressin

Published: 09/14/2020 11:38 GMT
(MNK) - Mallinckrodt Receives a Complete Response Letter From the U.S. Food and Drug Administration (fda) for Terlipressin for the Treatment of Hepatorenal Syndrome Type 1 (hrs-1).
Mallinckrodt Plc - Crl Stated That, Based on Available Data, Agency Cannot Approve Terlipressin NDA in Its Current Form.
Mallinckrodt Plc - Crl Stated FDA Requires More Information to Support Positive Risk-benefit Profile for Terlipressin for Patients With Hrs-1.
Mallinckrodt Plc - "surprised by and Disagree With FDA's Decision".