EU approves expanded use of Janssen’s Spravato
Treatment authorised for rapid reduction of depressive symptoms in a psychiatric emergency
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Tag: major depressive disorder
Janssen’s depression nasal spray Spravato bags new FDA approval
Drug approved to treat major depressive disorder with acute suicidal ideation or behaviour
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FDA rejects Alkermes’ depressive disorder drug
The US Food and Drug Administration (FDA) has rejected Alkermes’ filing for ALKS 5461 in major depressive disorder (MDD), asking for more clinical data.
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FDA advisors turn down Alkermes’ ALKS 5461
Alkermes’ ALKS 5461 has been hit with a potential setback in the US after regulatory advisors failed to back its approval for major depressive disorder (MDD).
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Alkermes boosted by trial success for antidepressant
Shares in Ireland-headquartered Alkermes shot up nearly 50 percent after its experimental depression drug hit targets in a pivotal late-stage trial.
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Second breakthrough badge for Janssen’s antidepressive
Janssen’s esketamine has picked up a breakthrough therapy designation in the US as a treatment for major depressive disorder with imminent risk for suicide, potentially speeding up development and review timelines.
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- BioMed X launches kidney disease project in partnership with the government of Barbados
