No stranger to head­winds, blue­bird runs in­to two PDU­FA de­lays un­re­lat­ed to new safe­ty is­sues

Blue­bird bio hit an­oth­er speed bump Tues­day in its ef­forts to win its first FDA ap­provals as reg­u­la­tors pushed back two PDU­FA dates.

The FDA de­layed the ac­tion dates for beti-cel and eli-cel, the one-time gene ther­a­pies for be­ta-tha­lassemia and cere­bral adrenoleukody­s­tro­phy, by three months each, the biotech said in a press re­lease Tues­day morn­ing. Orig­i­nal­ly sched­uled for May and June, re­spec­tive­ly, the new PDU­FA dates were pushed back to Au­gust and Sep­tem­ber.

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