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FDA decisions today

Page updated ·next FDA decision on the calendar ·Data as of Oct 16, 2026 12:20 PM ET
No FDA decision on a tracked application has been published today, October 16, 2026. The most recent was RHHBY's Enspryng (satralizumab) (Approved) on October 15, 2026. Decisions from the past week and the next scheduled dates are below.

Decided in the past week (2)

RHHBY · October 15, 2026 ✓ Approved
Enspryng (satralizumab)
IBRX · October 14, 2026 ✓ Approved
ANKTIVA (N-803) + BCG

Other FDA approvals recorded in the past week (1)

Original NDA/BLA approvals and new-indication supplements recorded in Drugs@FDA (openFDA) that are not goal dates on our calendar, by the FDA's own action date. openFDA posts records a few days after the action, and CBER products (vaccines, cell and gene therapies) are not in Drugs@FDA.

October 9, 2026 · REPATHA ✓ Approved
Amgen Inc · BLA 125522 S-47 · new indication (efficacy supplement) · evolocumab · our decision page

Next scheduled PDUFA dates

IRD · October 17, 2026 tomorrow
Phentolamine ophthalmic solution 0.75%
VTRS · October 17, 2026 tomorrow
MR-141 (phentolamine ophthalmic solution 0.75%)
GSK · October 26, 2026 in 10 days
Bepirovirsen
INO · October 30, 2026 in 14 days
INO-3107 DNA immunotherapy
AGIO · November 1, 2026 in 16 days
Mitapivat (PYRUKYND)
BTAI · November 14, 2026 in 29 days
IGALMI (dexmedetomidine sublingual film)
CYTK · November 14, 2026 in 29 days
Aficamten
SMMT · November 14, 2026 in 29 days
Ivonescimab

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.