Alkermes plc announced the publication of phase III ENLIGHTEN-1 trial of ALKS 3831 in the Journal of Clinical Psychiatry .
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Alkermes announced that the FDA has approved Lybalvi (olanzapine and samidorphan) for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate.
Alkermes plc announced the presentation of new research from its psychiatry portfolio at the 2021 Congress of the Schizophrenia International Research Society (SIRS), taking place virtually April 17-21, 2021.
Alkermes plc announced that the FDA has acknowledged receipt of the company's New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with bipolar I disorder, and has assigned the application a new Prescription Drug User Fee Act (PDUFA) target action date of June 1, 2021.