Viral Hepatitis
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2017-03-15Clinical Trial Update: Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients. [Phase 3]
Phase 3 trial update of Civacir, a polyclonal IgG, to prevent hepatitis C virus recurrence in liver transplant patients; study status is com…
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CLINICAL_TRIALS trial_result · 2017-01-26Clinical Trial Update: A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers [Phase 1]
A randomized, open-label, single-dosing, 2x2 crossover Phase 1 study comparing safety and pharmacokinetics of BR-TND Tablet (tenofovir disop…
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CLINICAL_TRIALS trial_result · 2016-12-19Clinical Trial Update: Safety and Efficacy of Gratisovir (Sofosbuvir)- Ribavirin Therapy in Pediatric Patients [Phase 2, Phase 3]
Phase 2/Phase 3 clinical trial assessing the safety and efficacy of Gratisovir (sofosbuvir) with ribavirin in pediatric patients. The curren…
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FDA approval · 2016-12-14FDA Tentative Approval: LAMIVUDINE — Supplemental Application (Strides Pharma Science Limited)
FDA issued tentative approval for Strides Pharma Science Limited's generic lamivudine under an ANDA, signaling potential US market approval …
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FDA approval · 2016-11-21FDA Approved: LAMIVUDINE — Original Application (Aurobindo Pharma Limited)
The FDA approved Aurobindo Pharma Limited's original ANDA for lamivudine, enabling a generic version of lamivudine to be marketed.
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FDA approval · 2016-11-21FDA Approved: LAMIVUDINE — Original Application (Ingenus Pharmaceuticals, LLC)
The FDA approved a generic lamivudine product under an Original Application filed by Ingenus Pharmaceuticals, LLC.
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EMA withdrawal · 2016-10-24EMA Application withdrawn: Cokiera — AbbVie Ltd
EMA has withdrawn the application for Cokiera by AbbVie Ltd.
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CLINICAL_TRIALS trial_result · 2016-09-27Clinical Trial Update: Treatment of Chronic Hepatitis With Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon: North India Gastroenterology Consortium
North India Gastroenterology Consortium completed a clinical trial evaluating sofosbuvir with ribavirin, with or without pegylated interfero…
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CLINICAL_TRIALS trial_result · 2016-09-09Clinical Trial Update: Renal Function Improvement in HBsAg Positive Kidney Transplantation Patients Under Telbivudine Treatment. [Phase 4]
Phase 4 trial investigating telbivudine for renal function improvement in HBsAg-positive kidney transplant recipients; the study has been te…
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CLINICAL_TRIALS trial_result · 2016-08-19Clinical Trial Update: ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS [NA]
A completed clinical trial investigating adrenal function in patients with acute hepatitis.
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CLINICAL_TRIALS trial_result · 2016-08-12Clinical Trial Update: Relative Bioavailability Study of GSK1265744 Formulations [Phase 1]
Phase 1 relative bioavailability study of cabotegravir formulations completed.
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FDA approval · 2016-07-20FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)
FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company.
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CLINICAL_TRIALS trial_result · 2016-04-21Clinical Trial Update: Comorbidities and Virologic Outcome Among Patients on Anti-retroviral Therapy in Rural Lesotho
This completed trial from rural Lesotho studied how comorbidities such as metabolic syndrome, depression, alcoholism, and hepatitis affect v…
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CLINICAL_TRIALS research · 2016-03-17Clinical Trial Update: Manhattan HIV/Hepatology Brain Bank
Completed clinical trial update for the Manhattan HIV/Hepatology Brain Bank studying HIV and hepatitis samples.
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FDA approval · 2016-03-10FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)
The FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) from Gilead Sciences, Inc.
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FDA approval · 2016-02-16FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) submitted by Gilead Sciences, Inc.
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FDA approval · 2016-02-16FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)
The FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) from Gilead Sciences, Inc., updating its labeling as …
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FDA approval · 2016-01-06FDA Approved: RIBAVIRIN — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for ribavirin from Aurobindo Pharma Limited, authorizing continued approval and use of the ribavirin…
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FDA approval · 2016-01-06FDA Approved: VIRAZOLE — Supplemental Application (Bausch Health US, LLC)
FDA approved a supplemental application for Virazole (ribavirin) submitted by Bausch Health US, LLC, resulting in labeling changes as part o…
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FDA label_change · 2015-12-31FDA Approved: LAMIVUDINE — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for lamivudine by Apotex Corp., indicating a labeling-related change under the ANDA.
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CLINICAL_TRIALS trial_result · 2015-12-16Clinical Trial Update: Transfusion Infections Pediatric Prospective Study (TRIPPS)
A completed pediatric prospective study (TRIPPS) evaluating transfusion infection risks associated with blood donors, including cytomegalovi…
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FDA approval · 2015-09-30FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)
The FDA approved a supplemental application for Epivir (lamivudine) submitted by ViiV Healthcare Company.
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FDA approval · 2015-05-29FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) submitted by Gilead Sciences, Inc. The action indicates a…
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FDA label_change · 2015-05-29FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate), authorizing changes to the product's labeling. The chang…
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FDA approval · 2015-03-23FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)
FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company.