Vanda Pharmaceuticals received FDA approval for Bysanti (milsaperidone) for acute treatment of bipolar I disorder and schizophrenia, preserving the company’s atypical antipsychotic franchise as older products approach patent expiry. The approval represents a straightforward regulatory success for Vanda after recent interactions with the agency. Bysanti’s clearance secures continuity in Vanda’s neuropsychiatric portfolio ahead of Fanapt’s expected loss of exclusivity in 2027 and provides the company with a marketed product to support near‑term commercial stability.