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Home › Calendar › July 2026

July 2026 FDA PDUFA decisions

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET
PDUFA target dates for July 2026, each row linked to its primary source. PDUFA target dates are FDA-set goal dates.
← June 2026August 2026 →
9 PDUFA dates
MRK · 2026-07-16 ✓
Approved: Lipfendra (enlicitide decanoate): Cardiovascular (FDA action date; no goal date on record)
OTSKY · 2026-07-24 ✓
Approved: Centanafadine: ADHD (FDA action date; no goal date on record)
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))
NVS · 2026-07-31 ✓
Approved: Pluvicto (lutetium Lu 177 vipivotide tetraxetan) with an ARPI - PSMA-positive metastatic hormone-sensitive prostate cancer
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.
CELCCORTMNKDMRKNVSOTLKOTSKYVERAVTRS