Currently the drug is available in the U.S. under an emergency use authorization. It is for the treatment of hospitalized patients with severe COVID-19.
However, securing FDA approval of its new drug application would clear the way for wider use of remdesivir.
“Today’s filing is an important milestone as we continue to partner with the U.S. government and healthcare authorities around the globe to address the treatment needs of patients with COVID-19,” said Merdad Parsey, MD, PhD, CMO of Gilead Sciences.
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