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Home › Calendar › July 2026

July 2026 FDA PDUFA decisions

Updated ·next FDA decision on the calendar
PDUFA target dates for July 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
← June 2026August 2026 →
4 PDUFA dates
MRK · 2026-07-16 ✓
Approved: Lipfendra (enlicitide decanoate): Cardiovascular
OTSKY · 2026-07-24 ✓
Approved: Centanafadine: ADHD
VERA · 2026-07-07 ✓
Approved: Atacicept: IgA Nephropathy
CORT · 2026-07-11 ✓
Approved: Relacorilant: Platinum-resistant ovarian cancer
CELC · 2026-07-17 ✓
Approved: gedatolisib
MNKD · 2026-07-26 ✓
Approved: FUROSCIX ReadyFlow Autoinjector (SCP-111)
OTLK · 2026-07-29 ✓
Approved: bevacizumab: Age-Related Macular Degeneration
VTRS · 2026-07-30 ✓
Approved: MR-100A-01(Low dose estrogen weekly patch (150 mcg norelgestromin and 17.5 mcg ethinyl estradiol))
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.
CELCCORTMNKDMRKOTLKOTSKYVERAVTRS