Beqalzi (sonrotoclax)
New molecular entityPriority review
- Region
- 🇺🇸 US
- Active substance
- sonrotoclax
- Company
- Beone Medicines Usa
- Status
- Approved
- FDA approval
- Wed 13 May 2026
- Designations
- New molecular entity, Priority review
- Application
- NDA220711
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Wed 13 May 2026🇺🇸 FDA approval
FDA approves Beqalzi (sonrotoclax), a new medicine
Beone Medicines Usa; NDA220711; 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.