Regulatory

Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 5, 2020.
FDA
Instead of detecting the virus, this device can help determine who might be at risk for intubation and mechanical ventilation.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 4, 2020.
FDA
On Tuesday, the FDA extended its review of the Supplemental Biologics License Application for Arzerra in this indication by three months.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 3, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 2, 2020.
U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn recently gave a speech to the Alliance for a Stronger FDA. In it, he suggested that some of the changes forced on the agency by the COVID-19 pandemic are likely to become permanent.
FDA
AbbVie won first-of-its-kind approval for a non-surgical treatment, Oriahnn, aimed at treating heavy menstrual bleeding due to uterine fibroids, a common non-cancerous tumor, in pre-menopausal women.
FDA
Tecentriq is an anti-PD-L1 checkpoint inhibitor. Avastin binds to the VEGF protein, which plays a significant role in the development and maintenance of blood vessels by cancer cells.
Although the U.S. FDA is very busy dealing with emergency use approvals for diagnostics and possible treatments for COVID-19, it is still evaluating and approving therapies for non-COVID-19 indications. Here’s a look at this week’s calendar.
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