FDA issued a recommendation on June 30, 2022 to COVID-19 vaccine manufacturers that indicated that they should include an Omicron subvariant BA.4/5 component in their vaccines.
PreventionGenetics said Thursday that it has been granted marketing authorization for its POMC/PCSK1/LEPR companion diagnostic as a Class II device by the US Food and Drug Administration.
Becton Dickinson has obtained the CE-IVD mark on a combined panel assay to detect SARS-CoV-2, influenza A and B, and respiratory syncytial virus. The assay runs on the firm's BD Max instrument and is now available in countries that recognize the CE mark, the firm said on Thursday.
On June 28, the National Health Commission of the PRC released the "COVID-19 Prevention and Control Plan (Ninth Edition)". Compared with the eighth edition, the following revisions were made:
In the past two years, due to the strong cash flow driven by COVID-19, the industrial parks of Chinese IVD enterprises have been ready to land.
On May 20, the customs statistical data platform updated the import and export data. The export value of China’s COVID-19 reagents in May was 1.394 billion yuan, which is less than 10% of the value in January.
Recently, a research team in Thailand said that it was the first case in the world that a cat transmitted novel COVID-19 to humans through sneezing.
FDA has issued an Emergency Use Authorization for the Moderna and Pfizer-BioNTech COVID-19 vaccines in children as young as six months old.
The World Health Organization's COVID-19 Technology Access Pool (C-TAP) initiative has entered into a nonexclusive sublicense agreement with Biotech Africa to manufacture a serology assay to detect previous SARS-CoV-2 infection.
Roche said on Wednesday that the US Food and Drug Administration has issued Emergency Use Authorization for the Cobas SARS-CoV-2 Duo assay.
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