AbbVie's investigational HCV regimen receives U.S. FDA breakthrough therapy designation

30 September 2016 - Breakthrough therapy designation granted based on Phase 2 clinical data for genotype 1 patients who failed previous ...

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New FDA documents reveal history of breakthrough therapy designation for Epclusa

5 August 2016 - Sofosbuvir with velpatasvir was originally granted fast track designation by the FDA on 30 September 2013 ...

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AbbVie receives U.S. FDA approval of once daily Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the treatment of genotype 1 chronic hepatitis C

25 July 2016 - New extended-release formulation is the first all-oral, co-formulated treatment containing the three direct-acting antiviral components of Viekira ...

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FDA approves Epclusa for treatment of chronic Hepatitis C virus infection

28 June 2016 - The U.S. FDA approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with ...

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AbbVie receives FDA approval of supplemental new drug application for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin in genotype 1b chronic hepatitis C patients with compensated cirrhosis

25 April 2016 - AbbVie today announced that the FDA has approved a supplemental new drug application for the use of ...

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Costly hepatitis C drugs for everyone?

1 September 2015 - New drugs to treat hepatitis C are tremendously effective — and tremendously costly — raising fears that ...

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FDA approves Technivie for treatment of chronic hepatitis C genotype 4

The U.S. Food and Drug Administration today approved Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for ...

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