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Rilpivirine and cabotegravir were approved for medical use in the European Union in December 2020, as two separate medications. [11] [12] In January 2021, the U.S. Food and Drug Administration (FDA) granted the approval of Cabenuva to ViiV Healthcare. [4] [8] The combination was approved for medical use in Australia in February 2021. [14] [15]
Cabotegravir in combination with rilpivirine is indicated for the treatment of human immunodeficiency virus type-1 (HIV-1) in adults. [1] [7] The combination injection is intended for maintenance treatment of adults who have undetectable HIV levels in the blood (viral load less than 50 copies/mL) with their current antiretroviral treatment, and when the virus has not developed resistance to ...
GSK Plc said on Monday that its HIV-focused unit ViiV Healthcare's cabotegravir injected drug and tablets got a positive opinion from the European Medicines Agency for marketing authorisation.
(not approved) (many companies) Yes Generics, e.g., Duovir-N: lamivudine zidovudine: nevirapine (not approved) (many companies) Yes Truvada: emtricitabine tenofovir disoproxil: August 2, 2004 Gilead Sciences: No Atripla: emtricitabine tenofovir disoproxil efavirenz: July 12, 2006 Gilead Sciences Bristol-Myers Squibb: Yes Complera (US) Eviplera ...
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
Australia approved on Thursday a social media ban for children aged under 16 after an emotive debate that has gripped the nation, setting a benchmark for jurisdictions around the world with one of ...
A Kennedy aide who worked at Children's Health Defense with him also did not immediately respond. RFK Jr. petitioned FDA in 2021 to revoke authorization of all COVID vaccines originally appeared ...
HPTN 083 is a 2016 clinical trial which compares cabotegravir injections with oral use of Emtricitabine/tenofovir as pre-exposure prophylaxis ("PrEP") for prevention of HIV/AIDS. The study seeks to test injectable PrEP as a way to remedy adherence for many patients on a daily pill regimen.