Hyrnuo (sevabertinib)
New molecular entityPriority review
- Region
- 🇺🇸 US
- Active substance
- sevabertinib
- Company
- Bayer Healthcare
- Status
- Approved
- FDA approval
- Wed 19 Nov 2025
- Designations
- New molecular entity, Priority review
- Application
- NDA219972
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Wed 19 Nov 2025🇺🇸 FDA approval
FDA approves Hyrnuo (sevabertinib), a new medicine
Bayer Healthcare; NDA219972; New molecular entity, Priority review; tablet · source
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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.