US FDA Heads Into October With Calm Approvals Forecast
Decision on Regeneron’s Ebola virus therapy, which uses a similar monoclonal antibody cocktail approach as the company’s COVID-19 therapy candidate, stands out among the 10 user fee goal dates in the coming month.
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Data from the first 275 patients in the trial are promising, but outside experts say they are wary of another hasty Emergency Use Authorization.
With just 10 user fee goal dates coming up, September could be break from the fast pace of FDA decisions over the summer.
US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.