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Home › Calendar › August 2026

August 2026 FDA PDUFA decisions

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET
PDUFA target dates for August 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
← July 2026September 2026 →
11 PDUFA dates
REPL · 2026-08-02 ✓
Approved: RP1 (vusolimogene oderparepvec) + nivolumab: Oncology
MRNA · 2026-08-05 ✓
Approved: mRNA-1010 - (P304)
LNTH · 2026-08-13 ✓
Approved: MK-6240
BMY · 2026-08-17 ✓
Approved: iberdomide, daratumumab, and dexamethasone vs. daratumumab, bortezomib, and dexamethasone - (EXCALIBER RRMM)
RARE · 2026-08-23 ✓
Approved: DTX401 AAV gene therapy (pariglasgene brecaparvovec)
RPRX · 2026-08-25 ✓
Approved: Ziihera
ZYME · 2026-08-25 ✓
Approved: zanidatamab
JAZZ · 2026-08-25 ✓
Approved: Ziihera (zanidatamab-hrii) - (HERIZON-GEA-01)
GILD · 2026-08-27 ✓
Approved: Lenacapavir
LLY · 2026-08-27 ✓
Approved: Mounjaro (tirzepatide) - cardiovascular risk reduction (SURPASS-CVOT)
REGN · 2026-08-31 ✓
Approved: 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).

Companies on this page

Every company listed above, with its full catalyst history, past FDA decisions and measured run-up into each one.
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