Vanda Pharms Inc
4 products tracked · names used in filings: Vanda Pharms Inc, Vanda Pharmaceuticals Ltd, Vanda Pharmaceuticals Inc.
Upcoming milestones
Quimilza: PDUFA target action date (Generalized Pustular Psoriasis (GPP))
Vanda Pharmaceuticals Inc. (VNDA); imsidolimab; BLA; status: set; "…Quimilza TM BLA for GPP under review by the FDA; PDUFA target action date of December 12, 2026"; filed 2026-10-28 · source
imsidolimab: PDUFA target action date (Generalized Pustular Psoriasis (GPP))
Vanda Pharmaceuticals Inc. (VNDA); imsidolimab; BLA; status: set; "…Imsidolimab BLA for Generalized Pustular Psoriasis accepted for FDA review; PDUFA target action date of December 12, 2026"; filed 2026-05-06 · source
Recent milestones
Bysanti: PDUFA target action date (bipolar I disorder and schizophrenia)
Vanda Pharmaceuticals Inc. (VNDA); milsaperidone; NDA; status: set; "…Bysanti TM (milsaperidone) NDA for bipolar I disorder and schizophrenia under review by the FDA; PDUFA target action date of February 21, 2026"; filed 2026-02-11 · source
FDA approves Bysanti (milsaperidone), a new medicine
Vanda Pharms Inc; NDA220358; New molecular entity; tablet · source
FDA approves Nereus (tradipitant), a new medicine
Vanda Pharms Inc; NDA220152; New molecular entity; capsule · source
tradipitant: PDUFA target action date (prevention of vomiting induced by motion)
Vanda Pharmaceuticals Inc. (VNDA); tradipitant; NDA; status: set; "Separately, the ongoing review of the pending, fully completed New Drug Application for tradipitant for the prevention of vomiting induced by motion remains on track, with a PDUFA target action date of December 30, 2025, positioning tradipitant as potentially the first new pharmacologic treatment for motion…"; filed 2025-12-04 · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇪🇺 | Fanaptum iloperidone | Refused | |
| 🇪🇺 | Fanaptum iloperidone | Application withdrawn | |
| 🇺🇸 | Bysanti milsaperidone | Approved | 2026-02-20 |
| 🇺🇸 | Nereus tradipitant | Approved | 2025-12-30 |
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.