Phase 3 Trial Evaluating Magrolimab Combo for MDS Discontinued for Futility
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Phase 3 Trial Evaluating Magrolimab Combo for MDS Discontinued for Futility

In 2020, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to magrolimab for the treatment of newly diagnosed myelodysplastic syndromes (MDS). This designation is designed to expedite…

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FDA Lifts Clinical Hold on Phase 1 AML and MDS Clinical Trial
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FDA Lifts Clinical Hold on Phase 1 AML and MDS Clinical Trial

Effective June 1, 2023, the FDA lifted its clinical hold on Foghorn Therapeutics’ Phase 1 study of FHD-286 dose escalation in patients with acute myeloid leukemia and myelodysplastic syndromes. The…

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New Cell Therapy Approved by the FDA to Reduce Risk of Infection After Transplant
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New Cell Therapy Approved by the FDA to Reduce Risk of Infection After Transplant

  Omisirge (omidubicel) is the first allogeneic (from a donor) product for SCT that has been the recipient of FDA approval. The FDA's nod moves Omisirge into the realm of…

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Myelodysplastic Syndromes: The FDA Grants Fast Track Designation for Eltanexor
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Myelodysplastic Syndromes: The FDA Grants Fast Track Designation for Eltanexor

  Karyopharm Therapeutics, a pharmaceutical company focusing on novel cancer therapies, has issued a statement via PR Newswire that the FDA has granted regulatory designations to eltanexor, Karyopharm’s Selective Inhibitor…

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Experimental Treatment Combination Shows Efficacy in Acute Myeloid Leukemia and Myelodysplastic Syndromes
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Experimental Treatment Combination Shows Efficacy in Acute Myeloid Leukemia and Myelodysplastic Syndromes

  Researchers acknowledge that the primary cause of failure of stem cell transplants is disease relapse. This holds true specifically for allogeneic hematopoietic stem cell transplants where a cancer patient…

Continue Reading Experimental Treatment Combination Shows Efficacy in Acute Myeloid Leukemia and Myelodysplastic Syndromes