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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.
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 ...
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It was approved for use in 2018 in Australia, [8] the European Union [7] and the United States [9] and in 2019 in New Zealand [10] and the United Kingdom; [11] a generic version was approved by the Drugs Controller General of India in 2019. [1]
Lenacapavir was approved for medical treatment in the European Union in August 2022, [10] [12] in Canada in November 2022, [5] [6] and in the United States in December 2022. [9] [11] [13] [14] It is the first of a class of drugs called capsid inhibitors to be approved by the US Food and Drug Administration (FDA) for treating HIV/AIDS. [11] [15]