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FDA Removes Partial Clinical Hold on Gilead’s MDS and AML Magrolimab Studies

2022.04.12 00:27

FDA Removes Partial Clinical Hold on Gilead's MDS and AML Magrolimab Studies
FDA Removes Partial Clinical Hold on Gilead’s (GILD) MDS and AML Magrolimab Studies

Gilead Sciences, Inc. (Nasdaq: NASDAQ:GILD) announced that the U.S. Food and Drug Administration (FDA) decided to remove its partial clinical hold on the company’s studies investigating magrolimab in combination with azacitidine in myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following its review of the comprehensive safety data from each trial.

“This is a significant milestone for Gilead and, more importantly, for patients diagnosed with these cancers,” Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences, said.

GILD shares are down 15% year-to-date.

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