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RSS FeedPosted by Michael Wonder on 21 Dec 2024
Gilead submits new drug application to US FDA for twice yearly lenacapavir for HIV prevention
19 December 2024 - Lenacapavir named 2024 “Breakthrough of the Year” by Science Magazine. ...
Posted by Michael Wonder on 24 Mar 2022
U.S. FDA approves streamlined process for initiating HIV therapy with Cabenuva (cabotegravir and rilpivirine), the first and only complete long-acting injectable HIV treatment
24 March 2022 - Adults living with HIV now have an option to start injectable regimen without the need for ...
Posted by Michael Wonder on 24 Feb 2021
ViiV Healthcare submits supplemental new drug application to US FDA for expanded use of Cabenuva (cabotegravir, rilpivirine) as an HIV treatment for use every 2 months
24 February 2021 - ViiV Healthcare announced today the submission of a supplemental new drug application to the US FDA for ...
Posted by Michael Wonder on 21 Jan 2021
FDA approves first extended release, injectable drug regimen for adults living with HIV
21 January 2021 - The U.S. FDA today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the ...
Posted by Michael Wonder on 01 Sep 2020
Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS
1 September 2020 - Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management ...
Posted by Michael Wonder on 13 Apr 2020
Gilead Canada submits supplemental new drug submission to Health Canada for Descovy for HIV pre-exposure prophylaxis
9 April 2020 - Submission supported by data from the DISCOVER trial, which evaluated the safety and efficacy of Descovy compared ...
Posted by Michael Wonder on 22 Aug 2019
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, ...
Posted by Michael Wonder on 11 Aug 2019
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 ...
Posted by Michael Wonder on 09 Jul 2019
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 ...
Posted by Michael Wonder on 03 Jul 2019
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 ...
Posted by Michael Wonder on 02 Jul 2019
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 ...
Posted by Michael Wonder on 30 Apr 2019
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 ...
Posted by Michael Wonder on 24 Jan 2019
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 ...
Posted by Michael Wonder on 30 Nov 2018
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 ...
Posted by Michael Wonder on 13 Jul 2018
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 ...