USFDA lifts partial clinical hold on studies evaluating magrolimab in combination with azacitidine: Gilead Sciences
Foster City: Gilead Sciences, Inc. has recently announced that the U.S. Food and Drug Administration (USFDA) has lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine. The FDA removed the partial clinical hold after a review of the comprehensive safety data from each trial.
With this decision from the FDA, enrollment in the U.S. can resume for the studies investigating magrolimab in combination with azacitidine in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).
"Gilead, in close coordination with regulatory authorities, is planning to re-open enrollment in the magrolimab studies that were placed on a voluntary hold outside of the U.S. The company is also working with the FDA regarding the remaining partial clinical hold affecting studies evaluating magrolimab in diffuse large B-cell lymphoma and multiple myeloma. The ongoing clinical studies evaluating magrolimab in solid tumors were not subject to the clinical hold," the company said in its recent release.
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