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The FDA’s Aug. 23 Emergency Use Authorization (EUA) for convalescent plasma to treat COVID-19 has left hospitals with a choice — give the treatment to individual patients under the EUA or enroll them in clinical trials that will help settle the question of the treatment’s safety and efficacy. Read More
Researchers from Moscow’s Gamaleya Research Institute have posted results from two phase 1/2 trials of their controversial COVID-19 vaccine, showing it was safe and induced the production of antibodies in all adult volunteers. Read More
The U.S. may be gearing up for vaccine distribution, but a World Health Organization (WHO) spokesperson said Friday that the international agency doesn’t expect to see widespread vaccination with a COVID-19 vaccine until the middle of next year, stressing that more time is needed for late-stage clinical trials. Read More
“The new technologies being funded … have the potential to transform the diagnostics landscape if their promise is proven in clinical studies,” said HHS Assistant Secretary for Health Brett Giroir. Read More
The product is the first commercial test for fully automated high-throughput systems that can identify and differentiate between SARS-CoV-2, influenza A and influenza B using a single sample, according to the company. Read More
The FDA has updated its guidance on the use of convalescent plasma to treat COVID-19 or in clinical trials of treatments to take account of the administration’s Aug. 23 Emergency Use Authorization (EUA). Read More
The FDA has ousted another high-ranking communications officer following fallout from FDA Commissioner Stephen Hahn’s misrepresentation of convalescent plasma as a COVID-19 treatment. Read More