Adquey (difamilast)
New molecular entity
- Region
- 🇺🇸 US
- Active substance
- difamilast
- Company
- Acrotech Biopharma
- Status
- Approved
- FDA approval
- Thu 12 Feb 2026
- Designations
- New molecular entity
- Application
- NDA219474
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Thu 12 Feb 2026🇺🇸 FDA approval
FDA approves Adquey (difamilast), a new medicine
Acrotech Biopharma; NDA219474; New molecular entity; ointment · source
Follow Adquey
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.