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Somerville-based Bluebird Bio expects delay on FDA sickle cell drug application

Por: The Boston Globe Business March 29, 2023

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Bluebird Bio Inc. expects to fall short of its goal to seek regulatory approval for its sickle cell gene therapy by the end of March, the latest setback for the struggling biotechnology company.The company may be able to file the application in a few weeks, depending on when the US Food and Drug Administration provides feedback about Bluebird’s drug manufacturing process, Chief Executive Officer Andrew Obenshain said in an interview. He still... + full article



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