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FDA approves Biktarvy label update with data for pregnant adults with HIV – Gilead Sciences

Written by | 5 May 2024

Gilead Sciences, Inc. announced the FDA approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25… read more.

FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV – ViiV Healthcare

Written by | 18 Apr 2024

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announced the FDA approved Dovato (dolutegravir/lamivudine) for the treatment of HIV-1… read more.

FDA approves Edurant Ped (rilpivirine) for certain pediatric patients Living with HIV-1 – Johnson & Johnson

Written by | 4 Apr 2024

Johnson & Johnson announced that the FDA has approved Edurant Ped (rilpivirine) for the treatment of HIV-1 in combination with other antiretroviral therapies (ARVs) in treatment-naïve children (with… read more.

FDA approves Trogarzo 90-second intravenous (IV) push loading dose for the treatment of HIV infection – Theratechnologies Inc

Written by | 29 Dec 2023

Theratechnologies Inc. announced that the FDA has approved the company’s Labelling Prior Approval Supplement to include a 2000-mg intravenous (IV) push loading dose for Trogarzo (ibalizumab-uiyk). IV push… read more.

National Medical Products Administration has approved for Vocabria (cabotegravir) in combination with Rekambys (rilpivirine), the first and only complete long-acting HIV-1 injectable treatment – Viiv HealthCare

Written by | 13 Nov 2023

GSK plc has announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders announced that the National Medical Products… read more.

Janssen submits supplemental new drug application to FDA seeking expanded pediatric indication for HIV-1 therapy Edurant

Written by | 4 Aug 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking to expand the indication of Edurant… read more.

Twice-yearly lenacapavir demonstrates sustained impact on health-related quality of life in people with HIV – Gilead Sciences

Written by | 30 Jul 2023

Gilead Sciences, Inc. presented new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including patient-reported outcomes (PRO) from the Phase II/III CAPELLA trial . These latest… read more.

A new technology offers treatment for HIV infection through a single injection

Written by | 20 Jun 2022

A new study from Tel Aviv University offers a new and unique treatment for AIDS which may be developed into a vaccine or a one time treatment for… read more.

Phase III CARISEL study of Vocabria + Rekambys shows long-acting regimen is achievable in HIV – ViiV Healthcare

Written by | 9 Feb 2022

ViiV Healthcare presented positive interim data from the Phase III CARISEL study of Vocabria + Rekambys (cabotegravir + rilpivirine), which was initiated and conducted during the COVID-19 pandemic…. read more.

FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV – ViiV HealthCare

Written by | 7 Jan 2022

ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, has announced it has made a regulatory submission to the… read more.

FDA approves expanded indication of Biktarvy for treatment of HIV-1 in pediatric populations – Gilead Sciences

Written by | 26 Oct 2021

Gilead Sciences, Inc. announced the FDA approved a new low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing… read more.

ViiV Healthcare submits extended approval request for tablet formulation of Triumeq for HIV to FDA

Written by | 18 Oct 2021

ViiV Healthcare has announced it has made a regulatory submission to the FDA for approval of a new dispersible tablet formulation of the fixed dose combination of abacavir,… read more.

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