← Back to Calendar

Dupixent (dupilumab)

Sanofi / Regeneron · $REGN

Standard Review Fast Track sBLA

PDUFA Date

February 28, 2026

Time Remaining

24d ago

Review Type

Standard (10 mo)

92%

Baseline PoA

Historical sBLA
approval rate

Dynamic PoA

Coming soon
xAI Sentiment

Indication

Allergic fungal rhinosinusitis (AFRS) — adults and children 6+

Key Notes

FDA APPROVED February 26, 2026 — 2 days ahead of PDUFA target date. Expands Dupixent label to include allergic fungal rhinosinusitis (AFRS) in adults and children aged 6+.

⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

← Back to Full Calendar