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August 2026 FDA PDUFA decisions

PDUFA target dates for August 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
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9 PDUFA dates
LNTH · 2026-08-13
MK-6240
PFE · 2026-08-17
Padcev
ALPMY · 2026-08-17
Pembrolizumab combination — Oncology (Priority Review)
HOOK · 2026-08-17
Pembrolizumab combination — Oncology (Priority Review)
CRBP · 2026-08-17
Pembrolizumab combination — Oncology (Priority Review)
NCNA · 2026-08-17
Pembrolizumab combination — Oncology (Priority Review)
RPRX · 2026-08-25
Ziihera
ZYME · 2026-08-25
zanidatamab
GILD · 2026-08-27
Lenacapavir
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).