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A production line of Remdesivir. Photo: Fadel Dawood/picture alliance via Getty Images

Gilead Sciences on Thursday received approval from the Food and Drug Administration for remdesivir, an antiviral treatment that has shown modest results against treating COVID-19.

Why it matters: It's the first and only fully FDA-approved drug in the U.S. for treating the coronavirus.

The big picture: The FDA issued an emergency use authorization in May after treatment with the drug was found to shorten some hospitalized patients' recovery time. The full approval would likely expand its use.

Worth noting: President Trump was treated with remdesivir when he was hospitalized with COVID-19 earlier this month. He also received an experimental monoclonal antibody cocktail and the steroid dexamethasone.

What they're saying: “Since the beginning of the COVID-19 pandemic, Gilead has worked relentlessly to help find solutions to this global health crisis,” Gilead CEO Daniel O’Day said in a statement.

  • “It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need.”

FDA Commissioner Stephen Hahn said in a statement: “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic."

  • "As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”

Go deeper

Updated Nov 30, 2020 - Health

Key information about the effective COVID-19 vaccines

Illustration: Sarah Grillo/Axios

The race for a COVID-19 vaccine is ramping up, with three major candidates now reporting efficacy rates of more than 90%.

Why it matters: Health experts say the world can't fully return to normal until a coronavirus vaccine is widely distributed. But each potential vaccine has its own nuances, and it's likely that multiple vaccines will be needed in order to supply enough doses for universal vaccination.

Scoop: FDA chief called to West Wing

Stephen Hahn. Photo: Mandel Ngan/AFP via Getty Images

White House Chief of Staff Mark Meadows has summoned FDA commissioner Stephen Hahn to the West Wing for a 9:30am meeting Tuesday to explain why he hasn't moved faster to approve the Pfizer coronavirus vaccine, two senior administration officials told Axios.

Why it matters: The meeting is shaping up to be tense, with Hahn using what the White House will likely view as kamikaze language in a preemptive statement to Axios: "Let me be clear — our career scientists have to make the decision and they will take the time that’s needed to make the right call on this important decision."

Dec 1, 2020 - Health

CDC panel: COVID vaccines should go to health workers, long-term care residents first

Hospital staff work in the COVID-19 intensive care unit in Houston. Photo: Go Nakamura via Getty

Health-care workers and nursing home residents should be at the front of the line to get coronavirus vaccines in the United States once they’re cleared and available for public use, an independent CDC panel recommended in a 13-1 emergency vote on Tuesday, per CNBC.

Why it matters: Recent developments in COVID-19 vaccines have accelerated the timeline for distribution as vaccines developed by Pfizer and Moderna undergo the federal approval process. States are preparing to begin distributing as soon as two weeks from now.