FDA de­clines to ap­prove Ul­tragenyx's San­fil­ip­po gene ther­a­py, cit­ing man­u­fac­tur­ing is­sues

The FDA hit Ul­tragenyx with a com­plete re­sponse let­ter for its AAV gene ther­a­py, called UX111, over man­u­fac­tur­ing is­sues. How­ev­er, the com­pa­ny be­lieves those is­sues …

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