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May 02, 2026
Laguna won FDA Breakthrough Device Designation for a blood-based schizophrenia test, while Neurocrine dosed the first patient in a Phase 2 trial of NBI-1117570.
Mar 26, 2026
The FDA approved milsaperidone for bipolar I disorder and schizophrenia, while COMP360 psilocybin met its primary endpoint in a second phase 3 trial for treatment-resistant depression. Phase 2a data showed intravenous DMT (SPL026) significantly reduced depressive symptoms in major depressive disorder patients.
Mar 12, 2026
The bipolar depression treatment pipeline includes over 10 therapies from 8+ companies, with recent Phase 3 trials initiated for azetukalner and multiple emerging drugs targeting novel pathways expected to launch by 2036.
Feb 25, 2026
The FDA approved BYSANTI (milsaperidone) for bipolar I disorder and schizophrenia in adults, and accepted Vanda's BLA filing for imsidolimab to treat Generalized Pustular Psoriasis with a target action date of December 12, 2026.
Feb 20, 2026
Vanda Pharmaceuticals received FDA approval for Bysanti (milsaperidone), an atypical antipsychotic for schizophrenia and manic or mixed episodes in bipolar I disorder. The drug will be available by the third quarter of 2026.
Feb 21, 2026
The U.S. Food and Drug Administration has approved Vanda Pharmaceuticals' Bysanti for treating schizophrenia and acute bipolar I disorder. The company expects to launch the drug in the third quarter of 2026.
Feb 21, 2026
The FDA has approved BYSANTI (milsaperidone), a new chemical entity for treating bipolar I disorder and schizophrenia in adults. The drug is Vanda's second approval in less than two months and is expected to launch in Q3 2026.
