Treats symptomatic tenosynovial giant cell tumor (TGCT). Sold as Romvimza. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 1 application for Vimseltinib (sold as Romvimza), first approved Feb 14, 2025, with 1 new use approved and 0 published complete response letters.
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Feb 14, 2025 | RomvimzaNDA 219304 ยท New molecular entity | Deciphera Pharms | 2 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number. Drugs@FDA
