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President Donald Trump is among those who have been treated with remdesivir, and FDA-approval could widen access to more patients.
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A panel of doctor and scientists raised questions about the expedited regulatory path the Food and Drug Administration is considering for COVID-19 vaccines.
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A milestone in the development of COVID-19 vaccines will take place Thursday when the Food and Drug Administration will ask a panel of experts for advice on how to evaluate the vaccines.
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The requirements laid out by the Food and Drug Administration in advice for drugmakers underscore why it's unlikely a vaccine could clear the agency before Election Day.
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Referring to a report that the FDA plans to tighten requirements for a vaccine, Trump said, "That sounds like a political move."
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President Trump announced on Sunday that the FDA granted emergency use authorization to treat COVID-19 patients with plasma from people who have recovered from the virus, based on "promising" results.
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The president criticized the FDA this week for not giving emergency use approval to an experimental treatment for COVID-19. Scientists argue that the therapy still lacks sufficient evidence.
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Gilead Science's remdesivir, an antiviral medicine being tested for treatment of COVID-19, would get a seven-year monopoly if approved by the Food and Drug Administration.
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An expert panel wants the Food And Drug Administration to withdraw its approval for Makena, because a large study shows the drug doesn't work. But some doctors say the evidence isn't clear-cut.
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As most Florida students return to school on Monday, doctors are urging their parents to consider vaccinations beyond those required by the state, like...