Saphnelo (anifrolumab-fnia)
New biologic
- Region
- 🇺🇸 US
- Active substance
- anifrolumab-fnia
- Company
- Astrazeneca Ab
- Status
- Approved
- FDA approval
- Fri 24 Apr 2026
- Designations
- New biologic
- Application
- BLA761451
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Fri 24 Apr 2026🇺🇸 FDA approval
FDA approves Saphnelo (anifrolumab-fnia), a new medicine
Astrazeneca Ab; BLA761451; New biologic; injection, vial · 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.