arrangement to shift almost in profits through an Irish entity in just two years" without paying Irish taxes. The company repatriated a portion of the Irish subsidiary's holdings, $28 billion, to the United States in 2018 following reductions of the corporate tax rate. For this it paid an estimated $5.5 billion in tax. Remdesivir Gilead sought and obtained orphan drug designation for remdesivir from the US Food and Drug Administration (FDA) on March 23, 2020. This designation is intended to encourage the development of drugs affecting fewer than 200,000 Americans by granting strengthened and extended legal monopoly rights to the manufacturer, along with waivers on taxes and government fees. Remdesivir became a candidate for treating COVID-19; at the time the status was granted, fewer than 200,000 Americans had COVID-19, but numbers were climbing rapidly as the COVID-19 pandemic reached the US, and crossing the threshold soon was considered inevitable. Gilead retains 20-year remdesivir patents in more than 70 countries. In 2021, remdesivir (tradename Veklury) generated more than $4.5 billion in annual revenues, and was Gilead's highest selling product. COVID-19 Emergency use authorization for remdesivir was granted in the U.S. on May 1, 2020, for people hospitalized with severe COVID-19. In September 2020 following a review of the evidence, the WHO issued guidance not to use remdesivir for people with COVID-19, as there was no good evidence of benefit. However, over 2020–22 with further clinical research, remdesivir had been approved for treatment of hospitalized people with COVID-19 in the United States, European Union, and multiple other countries. In 2022, the Canadian component of the WHO international Solidarity Trial reported that in-hospital people with COVID-19 treated with remdesivir had lower death rates (by about 4%) and reduced need for oxygen and mechanical ventilation compared to people receiving standard-of-care treatments. Regulatory approval Veklury received approval from the US Food and Drug Administration (FDA) in October 2020 use in hospitalized adults and children 12 years and older for treatment of severe COVID-19 infections. In January 2022, the FDA gave regulatory approval to Veklury for use in adults and children (12 years of age and older who weigh at least and are positive for COVID-19, not hospitalized, and are ill having high risk for developing severe COVID-19, including hospitalization or death. The FDA also provided Emergency Use Authorization for Veklury treatment of children under age 12 who are COVID-positive and not hospitalized, but have mild-to-moderate