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www.fdanews.com/articles/176305-gileads-hep-b-drug-shines-in-phase-3

Gilead’s Hep B Drug Shines in Phase 3

April 21, 2016

A once-daily Gilead Sciences’ candidate for hepatitis B matched Viread in two Phase 3 studies.

Gilead has submitted an NDA for tenofovir alafenamide to the FDA with results from the study. The PDUFA date is slated for November 11.

Regulatory applications also have been submitted for TAF to the European Union and Japan.

 

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