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Vancouver, Wash.-based drugmaker CytoDyn is seeking an Emergency Use Authorization (EUA) from the FDA for its HIV treatment leronlimab for the treatment of mild-to-moderate COVID-19 patients. Read More
Sinopharm’s COVID-19 vaccine generated antibodies at levels on par with some of its competitors, according to early trial data released by scientists connected with the company and other China-based research institutes. Read More
A potential COVID-19 treatment that uses mesenchymal stem cells (MSCs) has flown under the radar thus far, but the therapy has shown promise in early research, and phase 2/3 results that will likely come out in early fall could show that it’s a game changer. Read More
The FDA has finally put muscle behind its authority to fine flouters of the ClinicalTrials.gov reporting requirements, issuing a final guidance last week that confirms penalties of up to $10,000 per violation. Read More
The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) is developing a weakened strain of SARS-CoV-2 for use in human challenge trials in case they’re needed to fully evaluate COVID-19 vaccine and therapeutic candidates, though the institute says the controversial studies would not replace phase 3 trials. Read More
The U.S. government has chosen distribution giant McKesson as a “central distributor” of COVID-19 vaccines and supplies needed to administer them once an approval or emergency authorization is granted. Read More