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PHAR FDA decision dates

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET

PHAR has 1 upcoming FDA decision date; the nearest is Jan 30, 2027 for Joenja (leniolisib) lower doses - APDS, ages 4+ from 13 kg (. 2 past decisions are on record below, each on its own page. One event, one page: past decisions never share a URL with a live catalyst.

PHAR catalyst hub · full calendar

Upcoming

Jan 30, 2027 in 110 daysJoenja (leniolisib) lower doses - APDS, ages 4+ from 13 kg (sNDA)

Decided

Sep 11, 2026 ✓ ApprovedJoenja (leniolisib)Feb 1, 2026 CRLsource-verified