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December 2026 FDA PDUFA decisions

PDUFA target dates for December 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
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5 PDUFA dates
EXEL · 2026-12-03
zanzalintinib
VNDA · 2026-12-12
Milsaperidone
RHHBY · 2026-12-18
Giredestrant — ER+/HER2- metastatic breast cancer
MLYS · 2026-12-22
lorundrostat Dose 1 — Hypertension
COGT · 2026-12-30
CGT9486 — Advanced Gastrointestinal Stromal Tumors
Looking for an approval probability for these? We deliberately don't publish one — here's why, and what we show instead (verified history + base rates).