We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA yesterday updated its March guidance on managing clinical trials during COVID-19 by saying that sites can conduct patient visits via video conference with some advance planning. Read More
Sponsors of drugs to treat or prevent COVID-19 should focus on populations that are the hardest hit and least represented in clinical trials, including minorities and the elderly, according to a new FDA guidance released yesterday. Read More
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