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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TGA approves Descovy (emtricitabine with tenofovir alafenamide fumarate)

7 July 2016 - The TGA has approved Gilead Sciences' new dual combination product for patients with HIV infection. ...

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TGA publishes AusPAR for emtricitabine with elvitegravir and cobicistat and tenofovir alafenamide fumarate (Genvoya)

5 July 2016 - The TGA has published an AusPAR for Gilead's Genvoya. ...

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FDA approves treatment for AIDS symptoms

5 July 2016 - Insys says agency OKs Dronabinol oral solution after earlier application was rejected in 2014. ...

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European Commission grants marketing authorization for Gilead’s single tablet regimen Odefsey (emtricitabine, rilpivirine, tenofovir alafenamide) for the treatment of HIV

23 June 2016 - Odefsey is the second single tablet regimen containing the Descovy backbone and the third product in Gilead’s ...

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TGA approves Truvada for PrEP – next: put it on the PBS, say HIV advocates

6 May 2016 - Australians can now access HIV medication as a way of protecting themselves against HIV transmission. ...

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