Sevabertinib
Sold as Hyrnuo. Every FDA application for this active ingredient.
- First approved: Nov 19, 2025
- Applications: 1
- New uses approved: 1
- Complete response letters: 0
Applications
NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Nov 19, 2025 | HyrnuoNDA 219972 · New molecular entity | Bayer Healthcare | 1 | 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. Drugs@FDA