VANDA PHARMS INC
Approval Confirmed
Bysanti
bipolar I disorder and schizophrenia
Resolved
137days ago
Approval decision Β· Feb 20, 2026
What's at stake A final FDA approval decision on Bysanti for bipolar I disorder and schizophrenia is expected Feb 20, 2026.
β€œBYSANTI TM (milsaperidone) received FDA approval for bipolar I disorder and schizophrenia on February 20, 2026.”

Analyst note

NDA220358 new molecular entity / original approval

Provenance

2 sources on file.

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