Trials & Filings

Gilead HCV Treatment Approved

Sovaldi cleared in combination antiviral treatment regimens

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Gilead Sciences has received approval from the FDA for Sovaldi (sofosbuvir) 400 mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. The FDA granted Sovaldi Priority Review and Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options.   Sovaldi’s efficacy has been establish...

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