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February 2027 FDA PDUFA decisions

Updated ยทnext FDA decision on the calendar
PDUFA target dates for February 2027, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
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1 PDUFA dates
GILD · 2027-02-02
Yeztugo (lenacapavir) once-weekly oral
ARQT · 2027-02-23
ZORYVE (roflumilast) cream 0.05%
CGEM · 2027-02-27
CLN-081: Non Small Cell Lung Cancer
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.
ARQTCGEMGILD