Food and Drug Administration (FDA)

NEWS
Decentralized clinical trials gained a foothold in the pharmaceutical industry amidst the COVID-19 pandemic and will continue to be used once the pandemic ends, according to panelists at BIO 2020, speaking Thursday in a virtual session.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 12, 2020.
According to the report, at least 17 of this year’s 28 new drug shortages “are directly or indirectly prompted by events the current COVID-19 pandemic has brought on,” which includes the increased demand for anesthetics and other drugs used to facilitate intubation.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 10, 2020.
Mirum Pharmaceuticals entered 2020 with a significant bounce after the U.S. Food and Drug Administration turned an end-of-phase meeting into a pre-New Drug Application meeting for its lead asset, maralixibat, an investigational treatment being evaluated for pediatric patients with Alagille syndrome.
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.
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.
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