FDA — authorised 19 November 2025
- Application: NDA219972
- Marketing authorisation holder: BAYER HEALTHCARE
- Local brand name: HYRNUO
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 SEVABERTINIB in United States
FDA authorised SEVABERTINIB on 19 November 2025
Marketing authorisation
SEVABERTINIB in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is SEVABERTINIB approved in United States?
Yes. FDA authorised it on 19 November 2025.
Who is the marketing authorisation holder for SEVABERTINIB in United States?
BAYER HEALTHCARE holds the US marketing authorisation.