Human Immunodeficiency Virus Infection

• FDA approval · 2025-10-28
  FDA Approved: JULUCA — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for JULUCA (dolutegravir and rilpivirine) from ViiV Healthcare Company, updating the existing pr…

• EMA approval · 2025-07-25
  New injection for easier prevention of HIV infection in the EU and worldwide

  The European Medicines Agency announced the approval of lenacapavir as a long-acting injectable for HIV pre-exposure prophylaxis, administer…

• EMA approval · 2025-07-10
  EMA Authorised: Evotaz (cobicistat;atazanavir) — Bristol-Myers Squibb Pharma EEIG

  The European Medicines Agency authorised Evotaz, a fixed-dose combination of cobicistat and atazanavir, for the treatment of Human immunodef…

• FDA approval · 2025-04-11
  FDA Approved: APRETUDE — Supplemental Application (ViiV Healthcare Company)

  FDA approves a supplemental application for APRETUDE (cabotegravir) filed by ViiV Healthcare Company. The action modifies the drug's labelin…

• EMA approval · 2024-07-25
  EMA Authorised: Symtuza (darunavir;cobicistat;emtricitabine;tenofovir alafenamide) — Janssen-Cilag International NV

  The European Medicines Agency authorised Symtuza, a fixed-dose combination antiretroviral therapy (darunavir/cobicistat/emtricitabine/tenofo…

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• FDA approval · 2023-10-11
  FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Quinn Pharmaceuticals)

  The FDA approved a supplemental application for Tenofovir disoproxil fumarate from Quinn Pharmaceuticals, granting approval of its generic p…

• FDA approval · 2023-03-28
  FDA Approved: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (QUALLENT PHARMACEUTICALS HEALTH LLC)

  The FDA granted a supplemental approval for the emtricitabine and tenofovir disoproxil fumarate product from Quallent Pharmaceuticals Health…

• FDA approval · 2022-03-23
  FDA Approved: CABENUVA — Supplemental Application (ViiV Healthcare Company)

  FDA has approved a supplemental application for CABENUVA (cabotegravir and rilpivirine) submitted by ViiV Healthcare Company.

• FDA approval · 2021-12-20
  FDA Approved: APRETUDE — Original Application (ViiV Healthcare Company)

  FDA approved APRETUDE (cabotegravir) for HIV pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV-1 infection in adults and i…

• FDA approval · 2021-03-19
  FDA Approved: FOSAMPRENAVIR CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for fosamprenavir calcium from Mylan Pharmaceuticals Inc.

• FDA approval · 2018-05-15
  FDA Approved: TRUVADA — Supplemental Application (Gilead Sciences, Inc)

  The FDA approved a supplemental application for TRUVADA (emtricitabine and tenofovir disoproxil fumarate) submitted by Gilead Sciences, Inc.

• FDA approval · 2018-04-27
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company.

• FDA approval · 2018-04-27
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company.

• FDA approval · 2017-09-25
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for Epivir (lamivudine) submitted by ViiV Healthcare Company.

• FDA approval · 2015-07-28
  FDA Approved: STRIBILD — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for STRIBILD from Gilead Sciences. The supplement concerns STRIBILD, a fixed-dose combination antire…

• FDA approval · 2015-03-23
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company.

• FDA approval · 2013-07-23
  FDA Approved: EDURANT — Supplemental Application (Janssen Products, LP)

  The FDA approved a supplemental application for Edurant (rilpivirine hydrochloride) submitted by Janssen Products, LP, indicating an approve…

• FDA approval · 2008-08-11
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) by Gilead Sciences, Inc., updating the product's labe…

• FDA approval · 2008-07-30
  FDA Approved: KALETRA — Supplemental Application (AbbVie Inc.)

  FDA approved a supplemental application for KALETRA (lopinavir/ritonavir) submitted by AbbVie.