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FDA rejects Abeona cell therapy, asks for more manufacturing data

The Food and Drug Administration has rejected an experimental cell therapy for a rare skin condition, asking its developer, Abeona Therapeutics, to provide more information about how the treatment is made.

Abeona on Monday said the FDA issued a so-called complete response letter for the therapy, known as prademagene zamikeracel, or pz-cel. The company had sought approval for its use treating a form of epidermolysis bullosa, or EB.

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