Gilead files challenge to government patents for HIV prevention pill

21 August 2019 - Gilead Sciences took the unusual step of mounting a challenge to U.S. government patents on Wednesday, ...

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Patient groups push back against Gilead's pricey HIV prevention treatment

7 August 2019 - Gilead Sciences hopes to soon introduce a pricey new pill to prevent HIV in people at risk ...

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ViiV Healthcare announces start of first-ever study to identify and evaluate approaches to implementing its once-monthly injectable HIV treatment in clinical practice

9 July 2019 - The long-acting injectable regimen has been granted priority review status by the FDA, with a target approval ...

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ViiV Healthcare receives EU marketing authorisation for Dovato (dolutegravir/lamivudine), a new once-daily, single-pill, two-drug regimen for the treatment of HIV-1 infection

3 July 2019 - Authorisation based on GEMINI pivotal trials in which Dovato achieved non-inferior efficacy compared to a dolutegravir-based, three-drug ...

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FDA continues to encourage ongoing education about the benefits and risks associated with PrEP, including additional steps to help reduce the risk of getting HIV

1 July 2019 - The U.S. FDA approved Truvada (emtricitabine/tenofovir disoproxil fumarate) in 2004 for the treatment of HIV-1 infection in ...

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Janssen announces submission of new drug application to U.S. FDA for the first monthly, injectable, two drug regimen of rilpivirine and cabotegravir for treatment of HIV

29 April 2019 - If approved, the rilpivirine and cabotegravir regimen would be the first-ever long-acting injectable treatment for adults living ...

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U.S. FDA accepts sNDAs for Pifeltro (doravirine) and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate)

23 January 2019 - Potential new indication would expand use to allow treatment-experienced adults living with HIV-1 whose virus is suppressed ...

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FDA announces pilot program with WHO to expedite review of HIV drug applications

30 November 2018 - The U.S. FDA today announced a plan to work with the WHO to pilot a process to ...

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Gilead receives approval in Canada for Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for the treatment of HIV-1 infection

12 July 2018 - Gilead Sciences Canada today announced that Health Canada has granted a notice of compliance for Biktarvy (bictegravir ...

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TGA approves Odefsey

30 August 2016 - The TGA has approved Gilead's combination product for HIV-1 infection Odefsey. ...

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Janssen submits marketing authorisation application for darunavir-based single tablet regimen for treatment of HIV-1 to European Medicines Agency

12 September 2016 - Janssen today announced the submission of a Marketing Authorisation Application to the EMA, seeking approval for ...

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European Commission grants marketing authorization for Gilead’s once-daily Truvada for reducing the risk of sexually acquired HIV-1

22 August 2016  - Truvada is the first anti-retroviral medicine to be licensed in Europe for pre-exposure prophylaxis, in combination with ...

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First medicine for HIV pre-exposure prophylaxis recommended for approval in the EU

22 July 2016 - Truvada to enhance existing HIV prevention strategies. ...

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U.S. FDA approves Prezista (darunavir) for use in pregnant women with HIV

18 July 2016 - Data show Prezista is a safe and effective treatment option in pregnant women, with no reports of ...

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EMA publishes EPAR for Odefsey (emtricitabine with rilpivirine hydrochloride and tenofovir alafenamide fumarate)

8 July 2016 - The EMA has published an EPAR for Gilead Sciences' Odefsey. ...

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