On February 20, 2026, the U.S. Food and Drug Administration (FDA) approved Bysanti (milsaperidone) tablets for the treatment of acute manic or mixed episodes associated with bipolar I disorder and schizophrenia in adults, marking a significant advancement in psychiatric therapeutics. Bysanti is designated as a new chemical entity (NCE), expanding the atypical antipsychotic class with a profile linked to decades of clinical experience through its active metabolite. This approval offers...
FDA Approval of Bysanti (Milsaperidone): A New Option for Bipolar I Disorder and Schizophrenia
Shyam Tailor
