Genuine Biotech Co. Ltd.’s azvudine has been granted conditional approval by China’s NMPA for the treatment of COVID-19. The drug, first granted conditional approval from the NMPA to treat HIV-1-infected adults with high viral loads in July 2021, is the first domestically developed oral medicine approved to treat COVID-19 in China and was approved just 10 days after its application was submitted on July 15.
The controversy about the origins of the SARS-CoV-2 virus and the accusations that it escaped from the Wuhan Institute of Virology, or even that it was deliberately engineered there, could – possibly – be brought to a close by two papers published July 26, 2022.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Biogen, Cidara, Editas, ERC, Genuine, GBT, GSK, Inflarx, Ionis, LFB, Novavax, Sirnaomics.
An expert panel of Japan’s Ministry of Health, Labour and Welfare (MHLW) pushed back on recommending conditional approval for a second time for Shionogi & Co. Ltd.’s orally administered COVID-19 antiviral 3CL protease inhibitor, S-217622, also known as ensitrelvir.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, B.More, Bridgebio, Hookipa, Lepu, Matinas, Medexus, Qbiotics, Veru.
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