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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 was approved for medical use in the European Union in December 2020. [10] In December 2021, the U.S. Food and Drug Administration (FDA) approved cabotegravir for pre-exposure prophylaxis. [16] The FDA granted the approval of Apretude to Viiv. [16] Zimbabwe became the first African country to approve the drug in October 2022. [26]
In 2012, the FDA approved the drug for use as pre-exposure prophylaxis (PrEP), based on growing evidence that the drug was safe and effective at preventing HIV in populations at increased risk of infection. [41] The FDA has approved two additional medications for PrEP since then, approving Descovy in 2019 and Cabotegravir (Apretude) in 2021. [4 ...
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.
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 ...
In the judgment delivered on 1 December 2020, which has now been overturned on appeal, the judges said that it was highly unlikely that a child aged 13 or under would be competent enough to give consent to puberty blockers, and that it was doubtful that 14 or 15 year olds could understand the long-term risks and consequences associated with ...
The WHO recommends for children less than 3 years: [44] abacavir (or zidovudine) + lamivudine + lopinivir + ritonivir; and for children 3 years to less than 10 years and adolescents <35 kilograms: abacavir + lamivudine + efavirenz; US DHHS guidelines are similar but include PI based options for children > 3 years old. [61]
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.