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J&J’s Esketamine: A Model “Breakthrough” Program For US FDA

Executive Summary

J&J’s treatment-resistant depression drug esketamine had an easy time at an FDA advisory committee despite raising some tough regulatory questions. If you are looking for a showcase of how “Breakthrough” drug development collaboration can help a new therapy get to patients faster, this might be it.

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Janssen’s Esketamine Needs Better Defined REMS, US FDA Panel Says

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