ODINSIGNAL JOURNAL · NEWS & EVENTS
FDA Sets Dec 12 2026 PDUFA Target for Vanda’s Imsidolimab (Quimilza) in GPP
Vanda Pharmaceuticals’ imsidolimab (Quimilza) BLA for generalized pustular psoriasis has a FDA PDUFA target action date of Dec 12 2026.
At a glance
- Date
- December 12, 2026
Vanda Pharmaceuticals’ biologic Quimilza™ (imsidolimab) is currently under FDA review for generalized pustular psoriasis (GPP). The agency has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 12 2026 — the Biologics License Application is under review and the deadline is set in the PDUFA calendar Biopharma Transcript PDUFA calendar.
As of today, 8 November 2026, no regulatory decision has been announced. The outcome will be closely watched given the unmet need for effective GPP therapies.
Follow the event on OdinSignal for real‑time updates as the PDUFA date approaches.
FOLLOW THE EVENT
What happens next?
Explore the event, review its rules, and share your prediction on OdinSignal.
Explore the prediction market →Virtual credits only. No cash value.More from the Journal
OPEC to Hold 42nd Ministerial Meeting on 29 November 2026
OPEC and non‑OPEC participating countries will convene on 29 Nov 2026 for the 42nd Ministerial Meeting, reaffirming the current crude‑oil production framework.
Read article →U2’s 16th Studio Album ‘Carnaval De Luz’ Set for November 13, 2026 Release
Island Records confirms U2’s new album ‘Carnaval De Luz’ will drop on November 13, 2026, marking their first studio album of new material in nine years.
Read article →ICC to Open Rodrigo Duterte Trial on 30 November 2026
The International Criminal Court has scheduled the opening of Rodrigo Roa Duterte’s trial for 30 November 2026 in The Hague.
Read article →Prediction markets express uncertainty, not established outcomes. OdinSignal uses virtual credits with no cash value.