HIV Infection
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-01-25FDA Approved: DOVATO — Supplemental Application (ViiV Healthcare Company)
FDA approved a supplemental application for DOVATO (dolutegravir and lamivudine) from ViiV Healthcare.
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FDA approval · 2022-12-22FDA Approved: SUNLENCA — Original Application (Gilead Sciences, Inc.)
FDA approved Sunlenca (lenacapavir sodium) in an original application from Gilead Sciences for the treatment of HIV-1 infection. Lenacapavir…
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FDA approval · 2022-12-22FDA Approved: SUNLENCA — Original Application (Gilead Sciences, Inc.)
The FDA approved Sunlenca (lenacapavir sodium) from Gilead Sciences as an original NDA. This marks the introduction of a new antiretroviral …
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FDA approval · 2022-12-15FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for NORVIR (ritonavir) from AbbVie, resulting in updated labeling for the product. This action r…
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FDA approval · 2022-12-15FDA Approved: NORVIR — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for Norvir (ritonavir) submitted by AbbVie Inc.
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FDA approval · 2022-12-13FDA Approved: NEVIRAPINE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Nevirapine from Aurobindo Pharma Limited. This action updates the approval of Nevirapine, a …
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FDA approval · 2022-10-20FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)
FDA approved a supplemental application for PREZISTA (darunavir) submitted by Janssen Products LP. This action approves changes under the su…
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FDA approval · 2022-10-20FDA Approved: SYMTUZA — Supplemental Application (Janssen Products LP)
The FDA approved a supplemental application for SYMTUZA (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) from Janssen Produ…
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FDA approval · 2022-10-20FDA Approved: PREZCOBIX — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for PREZCOBIX (darunavir ethanolate and cobicistat) from Janssen Products, LP.
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FDA approval · 2022-10-20FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)
The FDA approved a supplemental application for PREZISTA (darunavir) submitted by Janssen Products LP.
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FDA approval · 2022-10-19FDA Approved: EDURANT — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for Edurant (rilpivirine hydrochloride) submitted by Janssen Products, LP.
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FDA approval · 2022-10-14FDA Approved: BIKTARVY — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for BIKTARVY (bictegravir, emtricitabine, and tenofovir alafenamide) from Gilead Sciences, Inc.
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FDA approval · 2022-10-07FDA Approved: TRIUMEQ — Supplemental Application (ViiV Healthcare Company)
FDA approved a supplemental application for TRIUMEQ (abacavir sulfate, dolutegravir sodium, lamivudine) from ViiV Healthcare Company.
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FDA approval · 2022-10-07FDA Approved: JULUCA — Supplemental Application (ViiV Healthcare Company)
FDA approved a supplemental application for JULUCA (dolutegravir sodium and rilpivirine hydrochloride) from ViiV Healthcare Company.
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FDA approval · 2022-10-07FDA Approved: DOVATO — Supplemental Application (ViiV Healthcare Company)
FDA approved a supplemental application for DOVATO (dolutegravir/lamivudine) submitted by ViiV Healthcare.
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FDA approval · 2022-10-07FDA Approved: TIVICAY — Supplemental Application (ViiV Healthcare Company)
The FDA approved a supplemental application for Tivicay (dolutegravir) submitted by ViiV Healthcare Company.
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FDA approval · 2022-10-07FDA Approved: TRIUMEQ PD — Supplemental Application (ViiV Healthcare Company)
FDA approved a supplemental application for TRIUMEQ PD, a fixed-dose combination of abacavir sulfate, dolutegravir sodium, and lamivudine fr…
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FDA approval · 2022-10-03FDA Approved: TROGARZO — Supplemental Application (Theratechnologies Inc.)
The FDA approved Theratechnologies' supplemental application for TROGARZO (ibalizumab), resulting in updated labeling and/or expanded use fo…
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FDA approval · 2022-09-29FDA Approved: DARUNAVIR — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' original ANDA for darunavir, establishing a generic version of the HIV-1 protease inhibitor for use in c…
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FDA approval · 2022-08-31FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for tenofovir disoproxil fumarate filed by Macleods Pharmaceuticals Limited under the ANDA process.
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FDA approval · 2022-07-25FDA Approved: ABACAVIR AND LAMIVUDINE — Original Application (Laurus Labs Limited)
FDA approved Laurus Labs Limited's generic fixed-dose combination tablet of abacavir and lamivudine (ABACAVIR AND LAMIVUDINE) under an Origi…
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FDA approval · 2022-04-14FDA Approved: PREZCOBIX — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for PrezcoBix (darunavir ethanolate and cobicistat) from Janssen Products, LP.
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FDA approval · 2022-04-14FDA Approved: PREZISTA — Supplemental Application (Janssen Products LP)
The FDA approved a supplemental application for PREZISTA (darunavir) submitted by Janssen Products LP.
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FDA approval · 2022-04-13FDA Approved: ETRAVIRINE — Original Application (Carnegie Pharmaceuticals LLC)
The FDA approved Carnegie Pharmaceuticals LLC's original-application for etravirine, allowing a generic version of the HIV-1 non-nucleoside …
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FDA approval · 2022-04-06FDA Approved: ABACAVIR, LAMIVUDINE AND ZIDOVUDINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for a generic fixed-dose combination of abacavir, lamivudine, and zidovudin…