FDA
The U.S. Food and Drug Administration (FDA), a day after a positive advisory committee recommendation, granted an Emergency Use Authorization (EUA) to Pfizer and BioNTech for their COVID-19 vaccine. Dosing is expected to begin in days.
All eyes on the FDA as they review a COVID-19 vaccine, FDA approval of an Emergency Use Authorization to LabCorp’s home test kit for COVID-19, the first testing device that does not require a prescription and more news.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 8, 2020.
Biopharma companies who have COVID-19 vaccines in development, have astonished skeptics by the speed with which they have developed vaccines.. But now comes an even more daunting challenge—scaling up manufacturing and distribution.
BioCryst Pharmaceuticals, Inc. announced on Thursday that the U.S. Food and Drug Administration (FDA) has approved ORLADEYO (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and young patients 12 years and older.
The U.S. Food and Drug Administration has given Emergency Use Authorization (EUA) to a COVID-19 test developed by Roche that measures antibodies within the blood.
The U.S. FDA approved Genentech and Blueprint Medicines’ Gavreto as a treatment for adults and pediatric patients 12 and above who have been diagnosed with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC).
The FDA uses special designations to get new, breakthrough treatments to patients in the greatest need.
The FDA approval was based on results from the largest studies conducted to date in obesity associated with POMC, PCSK1 or LEPR deficiency.
Despite the constant need for social distancing, mask-wearing, and the isolation and economic uncertainty that resulted from the outbreak, there is still much to be thankful for when families gather around a virtual table to break bread and carve the turkey this year.
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