Gilead Sciences‘ NDA for idelalisib, a targeted, oral inhibitor of PI3K delta, has been accepted for review by the FDA for the treatment of refractory indolent non-Hodgkin’s lymphoma (iNHL). FDA has granted a standard review for the NDA and has set a target review date under the Prescription Drug User Fee Act (PDUFA) of September 11, 2014. The NDA, submitted on September 11, 2013, was supported by a single-arm Phase II study evaluating idelalisib in patients with iNHL that is refractory (...