This is happening as more US states eased pandemic lockdowns despite another spike in deaths from the disease.
The approval is the latest step in a global push to find viable treatments and a vaccine for the coronavirus, which has left half of humanity under some form of lockdown, hammered the world economy.
Remdesivir, an antiviral drug initially developed to treat Ebola, was given the green light after a major trial found that it boosted recovery in serious COVID-19 patients.
The drug approval came as the US leaders struggled with growing pressure from citizens wearying of stay-at-home orders.
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