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U.S. FDA approves Gilead's Remdesivir for young children - Stone - 04-26-2022
U.S. FDA approves Gilead's COVID-19 drug for young children
April 25 (Reuters) - The U.S. drug regulator on Monday granted the first full approval for treating COVID-19 in children aged 28 days and older to Gilead Sciences Inc's (GILD.O) drug remdesivir.
The move comes months after the agency expanded the drug's emergency use authorization 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 hospitalized, or have mild-to-moderate disease and are at high risk of severe COVID-19.