Ambelvist (gadoquatrane)
New molecular entity
- Region
- 🇺🇸 US
- Active substance
- gadoquatrane
- Company
- Bayer Healthcare
- Status
- Approved
- FDA approval
- Fri 12 Jun 2026
- Designations
- New molecular entity
- Application
- NDA219627
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Fri 12 Jun 2026🇺🇸 FDA approval
FDA approves Ambelvist (gadoquatrane), a new medicine
Bayer Healthcare; NDA219627; New molecular entity; solution · 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.