Voyxact (sibeprenlimab-szsi)
New biologicPriority review
- Region
- 🇺🇸 US
- Active substance
- sibeprenlimab-szsi
- Company
- Otsuka Pharm Co Ltd
- Status
- Approved
- FDA approval
- Tue 25 Nov 2025
- Designations
- New biologic, Priority review
- Application
- BLA761434
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Tue 25 Nov 2025🇺🇸 FDA approval
FDA approves Voyxact (sibeprenlimab-szsi), a new medicine
Otsuka Pharm Co Ltd; BLA761434; New biologic, Priority review; injectable · 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.