Hepatitis B
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Sign up freeTop drugs studied for this disease
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EMA approval · 2024-09-17EMA Authorised: Vemlidy (tenofovir alafenamide fumarate) — Gilead Sciences Ireland UC
The European Medicines Agency authorised Vemlidy (tenofovir alafenamide fumarate) for the treatment of hepatitis B. The decision date was 26…
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EMA approval · 2024-07-24EMA Authorised: Entecavir Accord (Entecavir) — Accord Healthcare S.L.U.
The EMA authorised Entecavir Accord (entecavir) for chronic hepatitis B, confirming a generic entecavir product is now approved in the EU.
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EMA approval · 2024-06-07EMA Authorised: Lamivudine Teva (lamivudine) — Teva B.V.
The EMA authorised Lamivudine Teva (lamivudine) for chronic hepatitis B. Teva B.V. is the marketing authorisation holder.
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FDA approval · 2024-03-27FDA Approved: VEMLIDY — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for Vemlidy (tenofovir alafenam ide) submitted by Gilead Sciences, Inc. The document indicates a sup…
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EMA approval · 2024-02-08EMA Authorised: Ambirix (hepatitis A virus (inactivated);hepatitis B surface antigen) — GlaxoSmithKline Biologicals S.A.
Ambirix has been authorised for immunization against hepatitis A and hepatitis B infections.
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EMA approval · 2024-02-07EMA Authorised: Twinrix Paediatric (hepatitis A virus (inactivated);hepatitis B surface antigen) — GlaxoSmithKline Biologicals S.A.
EMA authorised Twinrix Paediatric, a hepatitis A and hepatitis B combination vaccine for paediatric use.
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EMA approval · 2024-02-07EMA Authorised: Twinrix Adult (hepatitis A virus (inactivated);hepatitis B surface antigen) — GlaxoSmithKline Biologicals S.A.
Twinrix Adult has been authorised by the EMA for hepatitis A and hepatitis B immunization.
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FDA approval · 2023-10-05FDA Approved: LAMIVUDINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for lamivudine, resulting in an approved generic lamivudine product. Lamivudine…
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FDA approval · 2023-06-12FDA Approved: ADEFOVIR DIPIVOXIL — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for Adefovir Dipivoxil from Apotex Corp., marking an approved change to the ANDA for this drug.
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EMA approval · 2023-05-24EMA Authorised: Fendrix (hepatitis B surface antigen) — GlaxoSmithKline Biologicals S.A.
Fendrix has been authorised for hepatitis B immunization in the European Union.
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FDA approval · 2023-04-25FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Tenofovir disoproxil fumarate by Aurobindo Pharma Limited. This approval relates to a generic pr…
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FDA approval · 2022-12-14FDA Approved: VEMLIDY — Supplemental Application (Gilead Sciences, Inc.)
The FDA approved a supplemental application for Vemlidy (tenofovir alafenamide) from Gilead Sciences. This action updates the regulatory sta…
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FDA approval · 2022-10-17FDA Approved: VEMLIDY — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for Vemlidy (tenofovir alafenamide) from Gilead Sciences. The action pertains to updating the produc…
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FDA approval · 2021-11-10FDA Approved: ENTECAVIR — Original Application (Carlsbad Technology, Inc.)
The FDA approved Carlsbad Technology, Inc.'s original application for entecavir (ENTECAVIR). This approval adds a generic option for the tre…
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FDA approval · 2021-03-04FDA Approved: VEMLIDY — Supplemental Application (Gilead Sciences, Inc.)
The FDA approved a supplemental application for Vemlidy (tenofovir alafenamide) filed by Gilead Sciences.
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FDA approval · 2020-11-13FDA Approved: ENTECAVIR — Supplemental Application (Solco Healthcare LLC)
FDA approved Solco Healthcare LLC's supplemental application for ENTECAVIR (entecavir) under ANDA208782.
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FDA approval · 2020-10-26FDA Approved: ADEFOVIR DIPIVOXIL — Supplemental Application (Sigmapharm Laboratories, LLC)
FDA approved a supplemental application for Adefovir Dipivoxil from Sigmapharm Laboratories, LLC.
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FDA approval · 2020-08-18FDA Approved: VEMLIDY — Supplemental Application (Gilead Sciences, Inc.)
The FDA approved a supplemental application for Vemlidy (tenofovir alafenamide) submitted by Gilead Sciences. The approval updates the produ…
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FDA approval · 2020-06-18FDA Approved: ENTECAVIR — Supplemental Application (NorthStar RxLLC)
The FDA approved NorthStar RxLLC's supplemental application for Entecavir (generic entecavir) under ANDA 206872.
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FDA approval · 2020-06-18FDA Approved: ENTECAVIR — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for ENTECAVIR from Aurobindo Pharma Limited under the ANDA, enabling continued marketing of the gene…
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FDA approval · 2020-06-18FDA Approved: ENTECAVIR — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application to allow Zydus Lifesciences Limited to market a generic entecavir (ENTECAVIR) in the United States.
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FDA approval · 2020-06-16FDA Approved: ENTECAVIR — Supplemental Application (AvKARE)
FDA approves a supplemental application for AvKARE to market entecavir, expanding the generic supply of the antiviral for chronic hepatitis …
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FDA approval · 2020-02-04FDA Approved: VEMLIDY — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for Vemlidy (tenofovir alafenamide) submitted by Gilead Sciences.
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FDA approval · 2020-01-07FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental ANDA for Tenofovir disoproxil fumarate from Macleods Pharmaceuticals Limited, authorizing a supplemental approva…
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FDA approval · 2019-12-13FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Tenofovir disoproxil fumarate from Aurobindo Pharma Limited. The approval covers this generic fo…