Avlayah (tividenofusp alfa-eknm)
New biologicPriority review
- Region
- 🇺🇸 US
- Active substance
- tividenofusp alfa-eknm
- Company
- Denali Therapeutics Inc.
- Status
- Approved
- FDA approval
- Tue 24 Mar 2026
- Designations
- New biologic, Priority review
- Application
- BLA761485
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Tue 24 Mar 2026🇺🇸 FDA approval
FDA approves Avlayah (tividenofusp alfa-eknm), a new medicine
Denali Therapeutics Inc.; BLA761485; New biologic, Priority review; injection · 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.