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FDA decisions today

Page updated ·next FDA decision on the calendar ·Data as of Oct 13, 2026 11:39 PM ET
No FDA decision on a tracked application has been published today, October 13, 2026. The most recent was RHHBY's Tecentriq (atezolizumab) (Approved) on October 8, 2026. Decisions from the past week and the next scheduled dates are below.

Decided in the past week (2)

RHHBY · October 8, 2026 ✓ Approved
Tecentriq (atezolizumab)
NVS · October 6, 2026 ✓ Approved
Rhapsido (remibrutinib)

Next scheduled PDUFA dates

RHHBY · October 15, 2026 in 2 days
Enspryng (satralizumab)
IRD · October 17, 2026 in 4 days
Phentolamine ophthalmic solution 0.75%
VTRS · October 17, 2026 in 4 days
MR-141 (phentolamine ophthalmic solution 0.75%)
GSK · October 26, 2026 in 13 days
Bepirovirsen
INO · October 30, 2026 in 17 days
INO-3107 DNA immunotherapy
AGIO · November 1, 2026 in 19 days
Mitapivat (PYRUKYND)
BTAI · November 14, 2026 in 32 days
IGALMI (dexmedetomidine sublingual film)
CYTK · November 14, 2026 in 32 days
Aficamten

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

Week view: FDA approval decisions this week, decided and pending, dated. Month view: this month.