Hepatitis C

• FDA approval · 2015-03-20
  FDA Approved: SOVALDI — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for Sovaldi (sofosbuvir) submitted by Gilead Sciences, Inc.

• EMA approval · 2014-11-21
  Two new medicines recommended for the treatment of chronic hepatitis C

  The EMA recommended two new medicines for the treatment of chronic hepatitis C, advancing options for patients with this condition.

• FDA approval · 2014-11-14
  FDA Approved: SOVALDI — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for Sovaldi (sofosbuvir) submitted by Gilead Sciences, Inc.

• FDA approval · 2014-10-10
  FDA Approved: LEDIPASVIR AND SOFOSBUVIR — Original Application (Asegua Therapeutics LLC)

  FDA approved Ledipasvir and Sofosbuvir under an Original Application filed by Asegua Therapeutics LLC for the treatment of hepatitis C.

• EMA approval · 2014-06-27
  European Medicines Agency recommends approval of Daklinza in chronic hepatitis C

  The European Medicines Agency recommends approval of Daklinza for use in chronic hepatitis C, indicating regulatory endorsement for its indi…

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• CLINICAL_TRIALS approval · 2014-01-16
  Clinical Trial Update: Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C

  This Clinical Trials Update describes an Expanded Access Program for Sofosbuvir with ribavirin, with or without pegylated interferon, to tre…

• FDA approval · 2013-12-06
  FDA Approved: SOVALDI — Original Application (Gilead Sciences, Inc.)

  The FDA approved Sovaldi (sofosbuvir) from Gilead as the original application, establishing it as a treatment for hepatitis C infection.

• EMA approval · 2013-11-22
  European Medicines Agency recommends approval of sofosbuvir for the treatment of chronic hepatitis C

  The EMA recommended approval of sofosbuvir for treating chronic hepatitis C, indicating a potential new therapy option for patients with thi…

• FDA approval · 2010-03-03
  FDA Approved: PEGASYS — Supplemental Application (pharmaand GmbH)

  FDA approved a supplemental application for PEGASYS (peginterferon alfa-2a) from pharmaand GmbH, approving an update to the biologics licens…