Government
Late Friday, the FDA gave the green light to Regeneron’s REGN-COV2, a combination of casirivimab and imdevimab.
The U.S. Food and Drug Administration (FDA) has a busy end of November planned, with numerous PDUFA dates to address. Here’s a look at the upcoming week.
With limited doses currently available, the logistics of inoculation are in the works and will certainly require guidance from the outgoing and incoming administrations of Donald Trump and Joe Biden, respectively.
The U.S. FDA has lifted a clinical hold on Cellectis’ Phase I MELANI-01 trial evaluating multiple myeloma candidate UCARTCS1 just months after working with the French biopharmaceutical company to adjust its trial protocol to enhance patient safety.
The U.S. Food and Drug Administration has four distinct approaches to speeding the drug approval process. Several of today’s announcements had one or more of these designations.
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.
The two companies received Complete Response Letters from the FDA this week, along with Sanofi.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 17, 2020.
Johnson & Johnson secured more than $1 billion in additional funding for its COVID-19 vaccine research through an expansion of its partnership with the Biomedical Advanced Research and Development Authority.
Late Friday, the regulatory agency rejected the medication of sutimlimab due to deficiencies from a pre-license inspection of a third-party manufacturing facility.
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