EU gives CE mark approval to SARS-CoV-2 (COVID-19) antibody microarray test as a diagnostic for COVID-19.- Quotient
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The board of directors of Shanghai Junishi Biosciences is pleased to announce that on 28 January 2023, pursuant to relevant regulations of the Drug Administration Law, the National Medical Products Administration (the NMPA) conducted urgent review and approval under Special Examination and Approval of Drugs and conditionally approved deuremidevir hydrobromide tablets (trade name: Mindewei, product code: VV116/JT001, “VV116”), an oral nucleoside analog anti-SARS-CoV-2 Category 1 innovative drug for marketing, which was applied by Shanghai Vinnerna Biosciences Co., Ltd a subsidiary controlled by the Company, for the treatment of adult patients with mild to moderate coronavirus disease 2019
Novavax participated in the FDA Vaccines and Related Biological Products Advisory Committee’s (VRBPAC) meeting, which resulted in a unanimous vote recommending harmonizing vaccine strain composition of primary series and booster doses. During the meeting, Novavax shared data demonstrating that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373), when used as a booster induces a broad functional immune response, including against forward drift variants.
The FDA has stated that AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorised for Emergency Use for pre-exposure prophylaxis (prevention) of COVID-19 in the US until further notice, due to the sustained high frequency of circulating SARS-CoV-2 variants that Evusheld does not retain in vitro neutralisation against