Food and Drug Administration (FDA)
NEWS
With Pfizer and Moderna lining up their COVID-19 vaccine candidates for EUA, the U.S. FDA announced it will make publicly available all data and information that will be used to consider authorization of vaccines and therapeutics against the virus.
This morning, the pharma giant signaled it will fail to meet a deadline related to $9 per share Contingent Value Rights (CVR) tickets, essentially killing that payment.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 17, 2020.
Late Friday, the regulatory agency rejected the medication of sutimlimab due to deficiencies from a pre-license inspection of a third-party manufacturing facility.
With the opinions that were expressed by the advisory committee, along with the data presented, the FDA will continue onward with its review process. It is expected to determine whether to approve the aducanumab Biologics License Application by March 7, 2021.
Here’s a look at some of the upcoming target action dates on the U.S. FDA’s calendar.
The company announced late Wednesday that its sickle cell disease gene therapy treatment will not be submitted to the U.S. Food and Drug Administration for two more years.
While the world has largely been focused on the development of vaccines and therapeutics for COVID-19, the U.S. FDA has remained busy lining up potential approvals of medications for other diseases and illnesses.
The COVID-19 pandemic changed the biopharma industry and the world irrevocably. The challenges will reverberate even after the pandemic ends, according to panelists at the Cell and Gene Meeting on the Mesa in mid-October.
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