pdufa.bio
CalendarDecisionsReadoutsRun-upStocks
Drug IndexConferencesAdvisory CommitteesScreenerResearchAPISLS trackerAccount
Pro
Home › Calendar › June 2026

June 2026 FDA PDUFA decisions

Updated ·next FDA decision on the calendar
PDUFA target dates for June 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
July 2026 →
5 PDUFA dates
ARVN · 2026-06-05 ✓
Approved: 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: Custirsen: Non-Small Cell Lung Cancer
UNCY · 2026-06-29 ✗
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: Donidalorsen
AZN · 2026-06-30 ✓
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.
ACHVARQTARVNAZNGSKIONSLNTHSPROUNCYVRDN