Vanda Pharmaceuticals Inc. gained U.S. FDA approval for Bysanti (milsaperidone), cleared for use in acute bipolar I disorder and schizophrenia and ensuring continuation of the firm’s atypical antipsychotic franchise, with Fanapt (iloperidone) set to start losing patent protection in 2027. It also offered a rare straightforward regulatory win for Vanda, which has tussled with the FDA in recent years.
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Acrotech, Astrazeneca, Breath Diagnostics, Daiichi, Dror Ortho Design, GE Healthcare, Hansa, Pilatus, Regeneron, Sibel, Skylinedx.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Angiodynamics, Briacell, Briapro, Cassava, Catheter Precision, Devonian, Johnson & Johnson, Senseonics, Sequel.
U.S. FDA approvals began 2026 at a slower pace than usual, with eight approvals recorded in January. The total falls below the 2025 monthly average of about 19 approvals and trails every month last year, which ranged from 12 to 27 approvals.