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FDA Gives Fast Track Designation to Givinostat for Polycythemia Vera
FDA Gives Fast Track Designation to Givinostat for Polycythemia Vera

May 6th 2025

The phase 3 GIV-IN PV trial is evaluating the efficacy and safety of givinostat vs hydroxyurea in patients with polycythemia vera.

Based on FDA feedback, the developers plan to discontinue the phase 3 EQUATOR study, which evaluated itolizumab in acute graft-versus-host disease.
FDA Rejects Breakthrough Designation, Approval for Itolizumab in Acute GVHD

April 25th 2025

An objective assessment tool like the ICE Score may standardize grading of neurotoxicity associated with newer bispecific antibodies in hematologic cancer.
Blinatumomab-Related ICANS Symptoms More Prevalent Than Prior Reports

April 11th 2025

The combination regimen was well tolerated in JAK inhibitor-naïve myelofibrosis, with instances of thrombocytopenia managed with dose modifications.
Pelabresib Plus Ruxolitinib Improves Spleen Responses in Myelofibrosis

March 17th 2025

Overall survival outcomes were enhanced with Orca-T vs allogeneic hematopoietic stem cell transplantation in patients with hematologic malignancies.
Orca-T Displays cGVHD-Free Survival Benefit in Hematologic Malignancies

March 17th 2025

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