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Gilead Submits New Drug Application to U.S. Food and Drug Administration for Fixed-Dose Combination of ...

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(Source: Gilead Sciences Inc) -- If Approved, Combination Would Be First All-Oral, Pan-Genotypic Single-Tablet Regimen for Chronic HCV Infection -- -- Filing is Company’s Third in Three Years for a New HCV Medicine -- FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 28, 2015-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® in December 2013, and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6...

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