WASHINGTON — The US Food and Drug Administration on Monday (April 25) granted approval for Gilead Sciences’ Covid-19 drug remdesivir to treat infants and children over 28 days of age.
The move comes months after the agency expanded the drug’s emergency use authorisation to also include children below 12 years of age weighing at least 3.5 kilograms.
The Food and Drug Administration’s (FDA) decision makes the drug the first approved Covid-19 treatment for children less than 12 years of age, the agency said.
The approval is applicable to children who are hospitalised, or have mild-to-moderate disease and are at high risk of severe Covid-19.
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