Gilead: FDA Places Partial Clinical Hold On Initiation Of New Patients In Magrolimab Studies

(RTTNews) - Gilead Sciences, Inc. (GILD) announced the U.S. Food and Drug Administration has placed a partial clinical hold on the initiation of new patients in U.S. studies evaluating magrolimab to treat acute myeloid leukemia. The company said the FDA action follows the discontinuation of the Phase 3 ENHANCE study of magrolimab in higher-risk myelodysplastic syndromes.

Gilead said the company is working with regulatory authorities to determine next steps to release the partial clinical hold. Studies of magrolimab in solid tumors continue without any impact from the FDA action.

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