U.S. FDA Accepts New Drug Application for Gilead’s Idelalisib for the Treatment of Refractory Indolent Non-Hodgkin’s Lymphoma

14-01-2014 Business Wire HealthComments (0)

Gilead SciencesidelalisibPharmaceutical

Gilead Sciences, Inc. (Nasdaq: 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. The NDA

Read more on Business Wire Health

Your Comments

Login to add a comment

There are no comments yet. Be the first and leave a response!

Back to top