Hemogenyx Pharmaceuticals plc announced that it has been informed by the U.S. Federal Food and Drug Administration that it has lifted the clinical hold on the Investigational New Drug (IND) application for HEMO-CAR-T for the treatment of acute myeloid leukemia. The FDA confirmed that the Company had addressed all issues identified in its prior clinical hold letter satisfactorily and consents to the Company proceeding with its Phase I clinical study of HEMO- CAR-T.
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- Hemogenyx Pharmaceuticals PLC Announces FDA Consents to Phase I Trials of HEMO-CAR-T