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Atara, Pierre Fabre will get another shot at FDA approval, a week after Prasad's departure
US regulators are willing to reconsider using a Phase 3 study of tab-cel as the basis for an approval, after previously rejecting the therapy based on that same study.
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statnews.com
FDA to reconsider treatment for rare cancer after its surprise rejection
The companies developing Ebvallo reached an agreement with the FDA to address its main reason for rejecting the drug.
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endpoints.news
Atara, Pierre Fabre will get another shot at FDA approval, a week after Prasad's departure
US regulators are willing to reconsider using a Phase 3 study of tab-cel as the basis for an approval, after previously rejecting the therapy based on that same study.