Regulatory
The game was reviewed through the agency’s de novo pathway and as a result, creates a new class of digital therapeutics.
The warning came only a few hours after the FDA rescinded Emergency Use Authorization (EUA) for hydroxychloroquine and chloroquine for the treatment of COVID-19.
Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received expedited approval from Health Canada to begin a Phase 2/3 clinical study of its investigational drug, EB05, which the company is developing as a potential treatment for moderate to severe COVID-19 patients.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 15, 2020.
Although clinical trials are often performed throughout different parts of the world, often their demographic makeup—the gender, age and race of participants—has a certain kind of uniformity.
Two weeks after announcing concerns about high-levels of carcinogens in popular diabetes drugs, the U.S. Food and Drug Administration announced the first voluntary recalls of this class of drugs manufactured by five companies.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 12, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 10, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 8, 2020.
The next two weeks are busy ones for the U.S. Food and Drug Administration (FDA). Here’s a look at PDUFA dates for this period.
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