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BioWorld - Thursday, December 18, 2025
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Home » Holds on four Bluebird gene therapy studies are released by the FDA
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Holds on four Bluebird gene therapy studies are released by the FDA

June 7, 2021
By Lee Landenberger
The FDA has lifted clinical holds on four studies from Bluebird Bio Inc., following recent similar actions with other gene therapy programs. Two of the studies concern phase I/II and phase III clinical trials of the gene therapy Lentiglobin (BB-1111) in treating sickle cell disease. The remaining two studies are phase III clinical trials of betibeglogene autotemcel gene therapy, which share a vector with Lentiglobin, for treating transfusion-dependent beta-thalassemia.
BioWorld Clinical Regulatory Hematologic Gene therapy FDA

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