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June 2027 FDA PDUFA decisions

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET
PDUFA target dates for June 2027, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
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2 PDUFA dates
URGN · 2027-06-14
UGN-103 (mitomycin): Oncology
MRK · 2027-06-15
Sacituzumab tirumotecan (sac-TMT) - endometrial cancer (TroFuse-005): Oncology
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.
MRKURGN