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BioWorld - Saturday, May 9, 2026
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Home » Celltrion wins Anvisa approval for COVID-19 antibody in first nod outside Asia
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Celltrion wins Anvisa approval for COVID-19 antibody in first nod outside Asia

Aug. 17, 2021
By Gina Lee
Celltrion Inc. has bagged its first green light outside Asia for its COVID-19 monoclonal antibody Regkirona (regdanvimab) with an emergency use authorization in Brazil. Brazil’s Anvisa gave the EUA for the drug to treat high-risk adult patients, including those aged 65 or older, with mild and moderate COVID-19 symptoms on Aug. 11. The regulator reached its decision on the drug, also known as CT-P59, via a unanimous vote.
BioWorld Asia Regulatory Antibody Asia-Pacific Latin America ANVISA

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