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In a widely reported interview over the weekend, FDA Commissioner Stephen Hahn said the agency is prepared to issue an Emergency Use Authorization for a COVID-19 vaccine before phase 3 trials are complete if the benefits outweighed the risks. Read More
The FDA has been accused of potentially fouling up its Aug. 23 Emergency Use Authorization (EUA) of convalescent plasma (CCP) for the treatment of COVID-19 by adding a requirement that each unit of plasma include information on the concentration of antibody titres. Read More
The European Commission announced Monday that it is participating in the World Health Organization’s international COVAX program for COVID-19 vaccines and is contributing $478 million. Read More
GlaxoSmithKline and Vir Biotechnology have dosed the first patient in a phase 2/3 clinical trial of their investigational COVID-19 antibody treatment VIR-7831 for early treatment in patients at high risk of hospitalization. Read More
The FDA has granted Abbott Laboratories an Emergency Use Authorization for its COVID-19 antigen test, a diagnostic that provides fast, readable results on a card similar to some pregnancy tests. Read More
In a dramatic policy reversal instigated by President Trump, the FDA will no longer require lab-developed tests (LDTs) for COVID-19 to undergo premarket review, the Department of Health and Human Services (HHS) announced Aug. 19. Read More
Two COVID-19 vaccine candidates being developed by Chinese pharma companies have already received emergency authorization in China, the country’s National Medical Products Administration (NMPA) revealed. Read More
Johnson & Johnson (J&J) says it will begin a phase 2 trial of its COVID-19 vaccine candidate in Spain, Germany and the Netherlands this week. Read More
Moderna said Friday that it is in talks with Japan’s Ministry of Health, Labor and Welfare to supply the country with at least 40 million doses of its COVID-19 vaccine. Read More
The UK has unveiled a proposal that would empower the Medicines and Healthcare Products Regulatory Agency (MHRA) to temporarily authorize effective COVID-19 vaccines while they are still under review. Read More
The FDA announced late Friday that it has decided to expand its Emergency Use Authorization (EUA) for Gilead Sciences’ remdesivir, allowing its use in patients with mild or moderate COVID-19 infections. Read More