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Pfizer: Paxlovid approved by FDA

( - Pfizer today announced that the US FDA has approved Paxlovid for the treatment of mild-to-moderate COVID-19 in adults at high risk of progression to severe COVID-19, including hospitalization or death.

Paxlovid has been available in the US since December 2021 under an emergency use authorization. Over 11.6 million treatments with Paxlovid have been prescribed in the US to date.

Paxlovid has become the first oral treatment for COVID-19 to be approved by the US FDA, underscoring the value it brings to patients, healthcare providers and healthcare systems, Pfizer said.

FDA approval is based on the body of scientific evidence shared by Pfizer, including safety and efficacy data from the EPIC clinical development program.

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