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The US FDA New Drug Approvals in February 2026 

Shots:  Approval momentum strengthened in February 2026, with the US FDA clearing four new therapies across dermatology, psychiatry, and rare pediatric disorders highlighting both volume and therapeutic impact.  Four notable therapies crossed the regulatory finish line, Acrotech Biopharma and Otsuka Pharmaceutical’s Adquey for mild-to-moderate atopic dermatitis, Vanda Pharmaceuticals’ Bysanti for acute bipolar I disorder and schizophrenia, Immedica Pharma’s Loargys for ARG1-D–related hyperargininemia, and Ascendis Pharma’s Yuviwel to improve growth in children with achondroplasia  Overall, February 2026 reflected…

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Vanda Pharmaceuticals

Vanda Pharmaceuticals Reports the US FDA’s Approval of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia

Shots: FDA has approved Bysanti, an active metabolite of iloperidone, as a 1L therapy for acute treatment of adults with manic or mixed episodes associated with bipolar I disorder & for schizophrenia, with the latest patent expiring in 2044 & commercial availability expected in Q3’26 In clinical trials, Bysanti showed bioequivalence to Fanapt (iloperidone) across the full…

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Vanda Pharmaceuticals

Vanda Pharmaceuticals Reports the US FDA’s NDA Acceptance of Bysanti (Milsaperidone) for Acute Bipolar I Disorder & Schizophrenia

Shots: The US FDA has accepted NDA of Bysanti, an active metabolite of iloperidone to treat acute bipolar I disorder & schizophrenia (PDUFA: Feb 21, 2026). If approved, Bysanti may receive 5yrs. of data exclusivity, with pending patents extending into the 2040s NDA is backed by various iloperidone trials, incl. 2 in acute schizophrenia, 1…

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