Regulatory
The EUA for the combination of Olumiant and Remdesivir marks the first combination for COVID-19 greenlit in the U.S.
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.
Late Friday, the regulatory agency rejected the medication of sutimlimab due to deficiencies from a pre-license inspection of a third-party manufacturing facility.
Several states have pledged to review COVID-19 vaccines themselves, after FDA emergency use authorizations, to ensure safety and efficacy. A robust review, however, is unlikely.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 10, 2020.
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.
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