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.
Keeping Track: Cloudy Horizon For Teplizumab, Roxadustat; Nuplazid Stumbles Over Subgroups; CAR-T Submissions From Gilead, J&J
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker