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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 ...
Cabotegravir is recommended in combination with safer sexpractices for pre-exposure prophylaxis to reduce the risk of sexually-acquired HIV-1 infection in high-risk adults and adolescents weighing ...
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 ...
Treatment of people aged twelve years of age and older with solid tumors that: have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy [2]
At the time of the 1990 decision, the FDA stated it "decided not to take action at that time, given the resources required to remove this authorization," as Red Dye No. 3 had already been approved ...
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 U.S. Food and Drug Administration’s accelerated approval program is meant to give patients early access to promising drugs. In a new study, researchers found that most cancer drugs granted ...
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