ROMVIMZA (VIMSELTINIB)
Summary
FDA approved ROMVIMZA (VIMSELTINIB) by DECIPHERA PHARMS. NDA (New Drug) approval (Efficacy) on 2026-06-26. CAPSULE, ORAL.
Details
Source
Drug Approval
External ID
NDA219304-2
Action Date
2026-06-26
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
ROMVIMZA (generic: VIMSELTINIB), CAPSULE, ORAL. Application: NDA219304
Company
Context & Analysis
DECIPHERA PHARMS has 2 FDA actions in our database.
Frequently Asked Questions
How often does DECIPHERA PHARMS have FDA actions?
DECIPHERA PHARMS has 2 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA219304-2" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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