FDA approves Omisirge as first approved cell therapy to treat severe aplastic anaemia

Ayrmid

5 December 2025 - Ayrmid announces that it has received US FDA approval for Omisirge (Omidubicel-onlv) for the treatment of severe aplastic anaemia.

This approval is based on the on-going open-label, single-center study, led by Dr. Richard Childs of the National Heart, Lung, and Blood Institute at the National Institutes of Health.

Read Ayrmid press release

Michael Wonder

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Michael Wonder