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The U.S. drug regulator on Monday granted the first full approval for treating COVID-19 in children age 28 days and older to Gilead Sciences Inc.'s drug remdesivir.
The move comes months after the agency expanded the drug's emergency use authorization to include children younger than 12 and 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 under 12 years old, 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.