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…

ByRidhi RastogiFebruary 23, 2026

INSIGHTS+

The US FDA New Drug Approvals in December 2025

Shots: Innovation peaked in December 2025, as the FDA delivered a wave of approvals spanning cardiometabolic disease, infectious disease, respiratory immunology, rare hematologic disorders, and acute cardiovascular and neurologic conditions highlighting both scientific breadth and clinical precision Seven notable therapies crossed the regulatory finish line, including LIB Therapeutics’ Lerochol for LDL lowering, Innoviva’s Nuzolvence for gonorrhea, GSK’s Exdensur for asthma with eosinophilic phenotype, Cytokinetics’ Myqorzo…

ByDipanshu DixitJanuary 13, 2026

NEWS

Vanda Pharmaceuticals Reports the US FDA Approval of Nereus (Tradipitant) to Prevent Vomiting Induced by Motion

Shots: The US FDA has granted Nereus for the prevention of vomiting induced by motion, backed by 3 trials, incl. 2 P-III real-world boat studies (Motion Syros & Motion Serifos) & 1 supporting study in pts with documented motion sickness In Motion Syros (n=365) & Motion Serifos (n=316), vomiting incidence was 18.3–19.5% & 10.4–18.3% vs 44.3%…

ByRidhi RastogiDecember 31, 2025

NEWS

Vanda Pharmaceuticals Seeks FDA Approval for Imsidolimab to Treat Generalized Pustular Psoriasis (GPP)

Shots: The FDA has received Vanda’s BLA for imsidolimab to treat GPP, with a priority review requested that could enable potential approval as early as mid-2026 BLA was supported by global P-III (GEMINI-1 & 2) trials, where GEMINI-1 (n=45) evaluated a single IV dose of imsidolimab (300 or 750mg) vs PBO, & GEMINI-2 re-randomized pts…

ByRidhi RastogiDecember 16, 2025

NEWS

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…

ByRidhi RastogiMay 6, 2025

NEWS

Vanda Pharmaceuticals Enters into an Exclusive Global License Agreement with AnaptysBio to Develop and Commercialize Imsidolimab

Shots: Vanda received exclusive rights to develop, manufacture & commercialize imsidolimab which has completed 2 P-III (GEMINI-1 & GEMINI-2) trials for generalized pustular psoriasis As per the terms, Anaptys will get $10M upfront, $5M for existing drug supply, & ~$35M in regulatory & sales milestones, plus 10% royalty on net sales, whereas Vanda will…

ByDipanshu DixitFebruary 4, 2025

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

The US FDA New Drug Approvals in December 2025

Vanda Pharmaceuticals Reports the US FDA Approval of Nereus (Tradipitant) to Prevent Vomiting Induced by Motion

Vanda Pharmaceuticals Seeks FDA Approval for Imsidolimab to Treat Generalized Pustular Psoriasis (GPP)

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

Vanda Pharmaceuticals Enters into an Exclusive Global License Agreement with AnaptysBio to Develop and Commercialize Imsidolimab

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