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  • MFDS is considering changing the permission of Remdesivir
  • by Lee, Tak-Sun | translator Choi HeeYoung | Dec 13, 2021 05:56am
It was discussed at the Central Pharmaceutical Affairs Council on the 7th
Will the controversy over the efficacy end?
Attention is focusing on whether COVID-19 treatment Veklury (Remdesivir) will be officially approved. In July last year, Veklury of Gilead Science Korea was conditionally licensed based on non-clinical test literature and interim clinical trial analysis results. At that time, the MFDS quickly approved the final results of clinical trials, some GMP data, and additional risk mitigation measures on the market.

According to the industry on the 9th, Veklury submitted data that satisfies the conditions granted at the time of approval to the MFDS and applied for permission to change. On the 7th, an advisory meeting of the Central Pharmaceutical Affairs Council was also held. For now, there is a high possibility of Veklury
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