Five months into receiving emergency use authorization, Remdesivir has finally been fully approved by the U.S. FDA as a treatment against COVID-19.
Thursday's approval makes the antiviral drug the first and only officially authorized treatment for the infectious disease in the U.S.
The FDA called "an important scientific milestone in the COVID-19 pandemic".
Made by U.S.-based Gilead Sciences, Remdesivir was initially developed to treat Ebola.
But it began being used as COVID-19 therapy in 50 countries, including the U.S., after one study showed the drug can cut patients' recovery time by five days.
In August, the scope of emergency use was also expanded to include mild and moderate patients, not just severe cases.
Those patients include President Trump, who used the drug in his fight against the virus.
"He'll receive another dose of Remdesivir here today and then we plan to get him home."
And now, under the official approval, Remdesivir will be given to hospitalized patients who are least 12 years old and weigh over 40 kilograms.
However, the WHO, based on its latest study, remains doubtful about the drug's effectiveness.
"Interim results from the (Solidarity) trial now show that the other two drugs in the trial, remdesivir and interferon, have little or no effect in preventing death from COVID-19 or reducing time in hospital."
Gilead criticized the WHO, saying their findings don't negate other positive results.
Despite the WHO's concerns, the drugmaker is set to ramp up production to make 2 million treatment courses by the end of this year.
Lee Kyung-eun, Arirang News.