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Home › Calendar › June 2026

June 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 June 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
July 2026 →
10 PDUFA dates
ARVN · 2026-06-05 ✓
Approved: VEPPANU (vepdegestrant, ARV-471): Advanced Breast Cancer
GSK · 2026-06-18 ✓
Approved: Tebipenem HBr (SPR994) - (PIVOT-PO)
SPRO · 2026-06-18 ✓
Approved: Tebipenem HBr (SPR994) - (PIVOT-PO)
ACHV · 2026-06-20 ✗
CRL: Cytisinicline: Smoking cessation (ORCA-3)
UNCY · 2026-06-29 ✗
CRL: CRL, Oxylanthanum Carbonate: Chronic Kidney Disease Requiring Chronic Dialysis
ARQT · 2026-06-29 ✓
Approved: ZORYVE (roflumilast) Cream 0.3%
LNTH · 2026-06-29 ✗
CRL: LNTH-2501 (Gallium-68 edotreotide)
VRDN · 2026-06-30 ✓
Approved: veligrotug
IONS · 2026-06-30 ✓
Approved: TRYNGOLZA (olezarsen): Severe hypertriglyceridemia (CORE)
AZN · Jun 2026 ✓
Approved: Truqap - (CAPItello-281)
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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