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The Coalition for Epidemic Preparedness Innovations (CEPI) is giving Novavax an additional $384 million for development of its COVID-19 vaccine. Read More
In a Senate hearing yesterday, FDA Commissioner Stephen Hahn said there is “a lot to be learned” from mishaps during the administration’s initial distribution of remdesivir for COVID-19 patients. Read More
To make remdesivir available to COVID-19 patients in low-income nations, Gilead Sciences has signed non-exclusive licensing agreements with five generic drugmakers to allow them to manufacture and sell the antiviral. Read More
The FDA has granted Moderna’s COVID-19 vaccine candidate a fast-track designation, making it the first potential vaccine to receive the agency’s expedited review status. Read More
The European Medicines Agency (EMA) has expanded its recommendations for compassionate use of Gilead Sciences’ remdesivir for patients with severe COVID-19. Read More
The National Institutes of Health is sponsoring a clinical trial of Gilead Sciences’ antiviral remdesivir combined with Eli Lilly’s anti-inflammatory Olumiant (baricitinib) for treatment of COVID-19 infections. Read More
The move is expected to minimize disruptions by reducing the need for on-site inspections where social distancing might be difficult to achieve, the agency said. Read More