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Gamida Cell’s Omisirge for SAA gets OK on limited data; more low-data FDA approvals likely to come

by rss feed | Dec 10, 2025 | FDA, Gamida Cell, News Feeds, Osimirge, Severe Aplastic Anemia

The FDA just announced it approved the cell therapy Omisirge from Gamida Cell for severe aplastic anemia (SAA). This is the first cell therapy approved for SAA. SAA is a rare, life-threatening blood disorder. It is often treated with hematopoietic stem cell...

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