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Home › Calendar › August 2026

August 2026 FDA PDUFA decisions

Updated ·next FDA decision on the calendar
PDUFA target dates for August 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
← July 2026September 2026 →
9 PDUFA dates
REPL · 2026-08-02 ✓
Approved: RP1 (vusolimogene oderparepvec) + nivolumab: Oncology
MRNA · 2026-08-05 ✓
Approved: mRNA-1010 - (P304)
LNTH · 2026-08-13
MK-6240
PFE · 2026-08-17
Padcev
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)
BMY · 2026-08-17
iberdomide, daratumumab, and dexamethasone vs. daratumumab, bortezomib, and dexamethasone - (EXCALIBER RRMM)
CAPR · 2026-08-22
Deramiocel (CAP-1002) - (HOPE-2)
RARE · 2026-08-23
DTX401 AAV gene therapy (pariglasgene brecaparvovec)
RPRX · 2026-08-25
Ziihera
ZYME · 2026-08-25
zanidatamab
JAZZ · 2026-08-25
Ziihera (zanidatamab-hrii) - (HERIZON-GEA-01)
GILD · 2026-08-27
Lenacapavir
REGN · 2026-08-31
Garetosmab - (OPTIMA)
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).

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BMYCAPRGILDJAZZLNTHMRNAPFERAREREGNREPLRPRXZYME