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FDA decisions today

Updated ยทnext FDA decision on the calendar
No FDA decision on a tracked application has been published today, September 1, 2026. The most recent was GILD's Bictegravir and Lenacapavir - (ARTISTRY- (Approved) on August 27, 2026. Decisions from the past week and the next scheduled dates are below.

Decided in the past week (3)

GILD · August 27, 2026 ✓ Approved
Bictegravir and Lenacapavir - (ARTISTRY-2)
JAZZ · August 25, 2026 ✓ Approved
Ziihera (zanidatamab-hrii) - (HERIZON-GEA-01)
ZYME · August 25, 2026 ✓ Approved
Ziihera (zanidatamab-hrii) - (HERIZON-GEA-01)

Next scheduled PDUFA dates

TLX · September 11, 2026 in 10 days
TLX101-Px
RARE · September 19, 2026 in 18 days
UX111 - (ABO-102)
MRK · September 21, 2026 in 20 days
WINREVAIR (sotatercept-csrk) - (HYPERION)
IONS · September 22, 2026 in 21 days
Zilganersen (ION373)
INCY · September 26, 2026 in 25 days
zilurgisertib
MIRM · September 26, 2026 in 25 days
zilurgisertib
BFRI · September 28, 2026 in 27 days
Ameluz (aminolevulinic acid hydrochloride) topical gel in combination with the R
NVO · September 30, 2026 in 29 days
Mim8 (denecimig)

Every upcoming FDA decision date on the 2026 PDUFA calendar · the full decisions archive