25 April 2022 - Today, the US FDA expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include paediatric patients 28 days of age and older weighing at least 3 kg with positive results of direct SARS-CoV-2 viral testing, who are hospitalised, or not hospitalised and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalisation or death.

This action makes Veklury the first approved COVID-19 treatment for children less than 12 years of age. As a result of today’s approval action, the agency also revoked the emergency use authorisation for Veklury that previously covered this paediatric population.

Read FDA press release