FDA Surprises Ariad with Early Nod for Ponatinib in CML, ALL
Ariad Pharmaceuticals Inc. got an unexpected holiday gift from the FDA, with the agency granting approval to its much-lauded pan BCR-ABL inhibitor, ponatinib, more than three months ahead of the drug's March 27, 2013, PDUFA date, and only two months after the Cambridge, Mass.-based firm completed a rolling new drug submission.
Ponatinib, which has been branded Iclusig, already had been slated for a priority six-month review based and accelerated approval had been widely expected by analysts.
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