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Gilead Sciences
GILD announced today that the U.S. Food
and Drug Administration (FDA) has accepted for review the company's New
Drug Application (NDA) for idelalisib, a targeted, oral inhibitor of
PI3K delta, for the treatment of refractory indolent non-Hodgkin's
lymphoma (iNHL). FDA has granted a standard review for the iNHL NDA and
has set a target review date under the Prescription Drug User Fee Act
(PDUFA) of September 11, 2014.
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