FDA Drug Approval Decisions Expected in February 2024

https://www.empr.com/home/news/drugs-in-the-pipeline/fda-drug-approval-decisions-expected-in-february-2024/

‘‘Roluperidone is an investigational 5-HT2A, sigma2 and α 1A-adrenergic receptor antagonist. The NDA submission included data from phase 3 MIN-101 study, which evaluated the efficacy and safety of roluperidone in 513 adult patients with moderate to severe negative symptoms of schizophrenia. Showed an improvement in negative symptoms (as measured by the Positive and Negative Syndrome Scale PANSS Marder Negative Symptoms Factor Score) in patients receiving roluperidone 64mg compared with placebo.’’

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