Supernus’ ADHD Drug Hits Phase III Endpoint As Filing Beckons
The first of two Phase III trials of Supernus’ ADHD candidate has hit its endpoints in adolescents. The second is due to report in early 2019, setting the stage for regulatory filings.
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Keeping Track Of User Fee Decisions And Filings: Adakveo, Brukinsa And Fetroja Mark Massive Week Of Novel Approvals
The latest news on US FDA user fee decisions and submissions to the agency.
Sunovion must find a new path forward for its dasotraline in attention deficit/hyperactivity disorder (ADHD), following a complete response letter from the US FDA.