The FDA approved Vanda Pharmaceuticals’ Bysanti for schizophrenia and for acute manic or mixed episodes in bipolar I disorder. Bysanti is an active metabolite of an existing atypical antipsychotic and represents a franchise‑extending approval for Vanda, broadening its neuropsychiatric product portfolio. The approval gives Vanda a marketed oral option across schizophrenia and selected bipolar indications. Vanda positioned the decision as a validation of its development strategy for central nervous system disorders. The clearance will be followed by commercialization activities focused on physician education and market access to drive uptake in the indicated populations.