Bluebird goes 2-for-2 on gene therapies at FDA adcomm with thumbs up for beti-cel
For the second straight day, the FDA’s Cellular, Tissue and Gene Therapies adcomm voted unanimously in favor of FDA approving a bluebird bio gene therapy, this time by a 13-0 vote in favor of beti-cel as a potential treatment for a blood disorder known as β-thalassemia for those who require regular blood transfusions.
The second straight unanimous thumbs up opens the potential for two FDA approvals later this summer for bluebird — although the agency on Friday raised some manufacturing concerns for both therapies.
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