Regeneron Pharmaceuticals campus in Tarrytown, New York.
The treatment is aimed at those with mild cases of COVID-19, and not for those hospitalized as a result of the virus, the FDA said.
The treatment works by mimicking the body’s own immune system to prevent the infected from become severely ill.
Regeneron’s drug is a combination of two monoclonal antibodies. A similar drug developed by Eli Lilly & Co. gained FDA emergency clearance earlier this month.
However the Regeneron treatment may not be immediately widely available: the company has said it will have just 80,000 doses by the end of November.