Johnson & Johnson announced today (6/10) that they will be initiating human trials in the second half of July for the Covid vaccine. The trials are expected to last over the course of two months in both the United States as well as Belgium, and will be...
The World Health Organization (WHO) has prequalified a biosimilar of version of rituximab, which is used to treat certain cancers and autoimmune diseases, created by Celltrion. This drug therapy is the second to achieve prequalification status under the...
The FDA released the app FDA MyStudies, which can be found in app stores as COVID MyStudies, for patients to provide informed consent for traditional clinical trials, real-world trials, observational studies, and registries. The app is free, as...
Due to the Covid pandemic, The Department of Health and Human Services granted Emergent BioSolutions a $628 million contract under the Biomedical Advanced Research and Development Authority (BARDA), a U.S. federal agency that funds disease-fighting technology in...
The FDA announced on Wednesday (5/27) new guidelines via a Q&A format for how Covid is impacting formal meetings, effective immediately. The guidance outlines that all meetings with the FDA will be held remotely, either through teleconference or video conference....
Today (5/18) Moderna announced that its Covid vaccine clinical trial in the United States has started to see protective antibodies in data from 8 healthy individuals, chosen at random from a 45-person study. The study, which began in March, and found that the...
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