Loargys (pegzilarginase-nbln)
New biologicPriority review
- Region
- 🇺🇸 US
- Active substance
- pegzilarginase-nbln
- Company
- Immedica Pharma Ab
- Status
- Approved
- FDA approval
- Mon 23 Feb 2026
- Designations
- New biologic, Priority review
- Application
- BLA761211
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Mon 23 Feb 2026🇺🇸 FDA approval
FDA approves Loargys (pegzilarginase-nbln), a new medicine
Immedica Pharma Ab; BLA761211; 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.