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BioWorld - Thursday, May 14, 2026
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Home » Oral COVID-19 antiviral Paxlovid wins full FDA approval
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Oral COVID-19 antiviral Paxlovid wins full FDA approval

May 25, 2023
Pfizer Inc.’s Paxlovid (nirmatrelvir/ritonavir) became the first oral antiviral to win full U.S. FDA approval for treating COVID-19, cleared for use in adults who are at high risk for progression to severe disease, including hospitalization or death. The nod follows two months after the agency’s Antimicrobial Drugs Advisory Committee voted 16-1 in favor of Paxlovid’s overall benefit-risk assessment.
BioWorld Regulatory Coronavirus U.S. FDA

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