Bluebird execs exhale after ruling sickle cell therapy 'very unlikely' to have caused AML event. How will FDA react?
Gene therapy player bluebird bio ran into a big stumbling block last month when they voluntarily placed a hold on their sickle cell program in the wake of two unexpected serious adverse events, a move that was shortly followed by the FDA making the hold official.
Now, after conducting further analyses, bluebird is confident that one of those events was probably not caused by the gene therapy, in a sigh of relief for a field that’s seen a raft of safety issues and scares over the last year.
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