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The system was chosen for the study “due to its record of increasing the efficacy of DNA vaccines and the speed of the delivery system compared to traditional needle and syringe,” the company said. Read More
The editors of the New England Journal of Medicine have broken with the medical journal’s long tradition of avoiding political issues and published a scathing criticism of the government’s management of the COVID-19 crisis, claiming that the FDA has been “shamefully politicized.” Read More
The price of dexamethasone, now in demand as a COVID-19 treatment, has increased dramatically in recent months and is poised to go up, the research group 46Brooklyn said. Read More
Dozens of medical experts from across the nation have written a letter to FDA Commissioner Stephen Hahn, Center for Biologics Evaluation and Research (CBER) Director Peter Marks and the FDA’s vaccine advisory committee calling for stronger requirements for monitoring participants in COVID-19 vaccine trials. Read More
Eli Lilly has submitted a request for an Emergency Use Authorization (EUA) for its monoclonal antibody LY-CoV555, following new positive trial data for its antibody combo in treating COVID-19. Read More
A benefit-risk evaluation of Gilead Sciences’ remdesivir by the UK’s Drug Safety Research Unit found the antiviral’s benefit-risk profile was “favorable” for COVID-19 patients. Read More
The HIV-1 antiviral drug combination lopinavir-ritonavir, marketed by AbbVie under the brand name Kaletra, has shown no benefit in reducing all-cause mortality among patients hospitalized with COVID-19 in the UK’s RECOVERY trial. Read More
The European Medicines Agency (EMA) began its second expedited review of a COVID-19 vaccine candidate, starting its evaluation of data for Pfizer/BioNTech’s vaccine hopeful BNT162b2 on Tuesday. Read More
GlaxoSmithKline (GSK) and Vir Biotechnology have begun enrolling participants in phase 3 trials to assess the safety and efficacy of their monoclonal antibody, VIR-7831, in treating COVID-19 infections early on in high-risk patients. Read More
Rick Bright, the former director of NIH’s Biomedical Advanced Research and Development Authority (BARDA), has resigned from the institute, alleging that its leadership failed to assign him meaningful work and ignored his recommendations because of politics. Read More
Despite the White House reportedly blocking the FDA’s tighter requirements for COVID-19 vaccine Emergency Use Authorizations (EUAs), the agency has opted to release them. Read More