Hepatitis B
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-07-01FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approves Teva's supplemental application for the generic fixed-dose combination emtricitabine and tenofovir disoproxil fumarate for the …
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CLINICAL_TRIALS trial_result · 2019-06-27Clinical Trial Update: Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4 to 5 Year Old Children Previously Vaccinated With Vaxelis® or INFANRIX® Hexa (V419-012) [Phase 3]
Phase 3 trial update on long-term persistence of hepatitis B and pertussis antibody responses in healthy 4–5 year-old children previously va…
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CLINICAL_TRIALS trial_result · 2019-06-26Clinical Trial Update: Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating Chronic Hepatitis B Patients [Phase 2]
Phase 2 trial update for a Mimogen-based therapeutic Hepatitis B vaccine used with Entecavir in chronic Hepatitis B patients; study complete…
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CLINICAL_TRIALS trial_result · 2019-06-04Clinical Trial Update: Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment [Phase 2]
Phase 2 trial evaluating safety and efficacy of GS-4774 in combination with tenofovir disoproxil fumarate for chronic hepatitis B; study com…
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FDA approval · 2019-05-31FDA Approved: ENTECAVIR — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for Entacavir by Camber Pharmaceuticals, expanding the availability of a generic entecavir product. …
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CLINICAL_TRIALS trial_result · 2019-05-24Clinical Trial Update: Immunogenicity and Persistence of Hepatitis B Vaccination in Methadone Maintenance Treatment Patients [Phase 4]
Phase 4 clinical trial updating immunogenicity and persistence of Hepatitis B vaccination in patients undergoing methadone maintenance treat…
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CLINICAL_TRIALS trial_result · 2019-05-24Clinical Trial Update: Research on Optimal Immunization Strategy of Hepatitis B Vaccine in Chronic Kidney Disease Population [Phase 4]
Phase 4 clinical trial update exploring optimal immunization strategy for Hepatitis B vaccine in individuals with chronic kidney disease.
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CLINICAL_TRIALS trial_result · 2019-05-24Clinical Trial Update: Immunogenicity and Persistence of Hepatitis B Vaccination in HIV-Infected Patients [Phase 4]
A Phase 4 clinical trial evaluating immunogenicity and persistence of Hepatitis B vaccination in HIV-infected patients.
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CLINICAL_TRIALS trial_result · 2019-05-20Clinical Trial Update: Utilization and Efficacy of Tenofovir DF in Adolescents With Chronic Hepatitis B Virus Infection [Phase 4]
Phase 4 trial update on the use of Tenofovir DF in adolescents with chronic hepatitis B, terminated with posted results.
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FDA approval · 2019-05-13FDA Approved: ENTECAVIR — Supplemental Application (NorthStar RxLLC)
FDA approved a supplemental application for Entacavir (ENTECAVIR) filed by NorthStar RxLLC under ANDA 206872.
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CLINICAL_TRIALS trial_result · 2019-05-08Clinical Trial Update: Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B [Phase 2]
Phase 2 trial update on combination therapy REP 2139-Ca with Pegasys for chronic hepatitis B completed with posted results.
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FDA approval · 2019-05-01FDA Approved: LAMIVUDINE — Original Application (Macleods Pharmaceuticals Limited)
FDA approved Macleods Pharmaceuticals Limited's original application for lamivudine (generic). Lamivudine is used in combination therapy for…
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CLINICAL_TRIALS trial_result · 2019-04-26Clinical Trial Update: TAF Switch in F3/4 CHB pt With Partial Response to NUC (ESTAB-AFPVR) [Phase 4]
Phase 4 clinical trial update on TAF switch in hepatitis B patients with partial response to nucleos(t)ide therapy (ESTAB-AFPVR).
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FDA approval · 2019-04-16FDA Approved: ENTECAVIR — Supplemental Application (AvKARE)
FDA approved a supplemental application for AvKARE to market entecavir, a hepatitis B antiviral, creating availability of a generic version.…
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CLINICAL_TRIALS trial_result · 2019-04-16Clinical Trial Update: A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection [Phase 2]
Phase 2 multi-dose study of ARC-520 for chronic hepatitis B patients who are HBeAg-negative was terminated, with results posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-04-16Clinical Trial Update: A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection [Phase 2]
A Phase 2 multi-dose trial of ARC-520 in HBeAg-positive chronic hepatitis B patients was terminated, with results posted in 2019.
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CLINICAL_TRIALS trial_result · 2019-04-16Clinical Trial Update: Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection [Phase 2]
Extension phase 2 trial of ARC-520 for chronic Hepatitis B was terminated, and results have been posted.
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CLINICAL_TRIALS trial_result · 2019-04-12Clinical Trial Update: Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV) [Phase 2]
Phase 2 study of ARC-520 for chronic hepatitis B with or without other drugs was terminated; results were posted in 2019.
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FDA approval · 2019-04-04FDA Approved: ENTECAVIR — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for entecavir filed by Zydus Lifesciences Limited under an ANDA.
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CLINICAL_TRIALS trial_result · 2019-03-21Clinical Trial Update: Hepatitis B Booster Study in Adolescence [Phase 4]
Phase 4 clinical trial evaluating a hepatitis B booster in adolescence has completed with results posted in 2019.
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FDA approval · 2019-03-21FDA Approved: LAMIVUDINE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' generic lamivudine as an original generic application for HIV-1 infection and chronic hepatitis B. This…
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CLINICAL_TRIALS trial_result · 2019-03-18Clinical Trial Update: Tenofovir Versus Tenofovir + Telbivudine for Chronic Hepatitis B [Phase 4]
Phase 4 clinical trial comparing tenofovir monotherapy to tenofovir combined with telbivudine for chronic hepatitis B; status currently unkn…
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CLINICAL_TRIALS trial_result · 2019-03-13Clinical Trial Update: Entecavir for Biological Agents Associated HBV Reactivation in Inflammatory Arthritis Patients [Phase 4]
Phase 4 trial updating entecavir use for preventing hepatitis B reactivation in patients with inflammatory arthritis undergoing biological a…
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FDA approval · 2019-03-10FDA Approved: ENTECAVIR — Supplemental Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's supplemental application to market entecavir (ENTECAVIR) as a generic, expanding access for treatmen…
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CLINICAL_TRIALS trial_result · 2019-02-26Clinical Trial Update: Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant [Phase 2]
Phase 2 trial comparing Tenofovir Alafenamide (TAF) to TDF-containing regimens in chronic hepatitis B patients with stage 2+ chronic kidney …