# July 2026 PDUFA Calendar: FDA Decision Dates & Biotech Catalysts

Canonical URL: https://biopharmsignal.com/pdufa-calendar/2026/july

BioPharmSignal tracks active PDUFA and FDA decision milestones for July 2026.

## PDUFA Events In July 2026

- 2026-07-07 — VERA — Vera Therapeutics
  Stage: PDUFA
  Summary: Atacicept treating IgA nephropathy
  Company page: https://biopharmsignal.com/company/VERA
- 2026-07-17 — CELC — Celcuity
  Stage: PDUFA
  Summary: Gedatolisib + palbociclib + fulvestrant (gedatolisib triplet) treating HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer (ABC)
  Company page: https://biopharmsignal.com/company/CELC
- 2026-07-26 — MNKD — MannKind
  Stage: PDUFA
  Summary: FUROSCIX ReadyFlow™ Auto-Injector Injection (furosemide) treating Edema in Adults with Chronic Heart Failure (CHF) or Chronic Kidney Disease (CKD)
  Company page: https://biopharmsignal.com/company/MNKD
- 2026-07-29 — OTLK — Outlook
  Stage: PDUFA
  Summary: ONS-5010 / LYTENAVA™ (bevacizumab-vikg) treating Wet age-related macular degeneration (AMD)
  Company page: https://biopharmsignal.com/company/OTLK
- 2026-07-30 — VTRS — Viatris Inc.
  Stage: PDUFA
  Summary: Low Dose Estrogen Weekly Patch (Transdermal Contraceptive) treating Contraception
  Company page: https://biopharmsignal.com/company/VTRS

## How To Use This Page

Use the event date, ticker, company, and stage to understand which regulatory decisions may matter during the month. Open the company page for recent news and stock context.

## FAQ

### What is listed on the July 2026 PDUFA calendar?

This page lists active BioPharmSignal PDUFA and FDA decision milestones dated in July 2026, including ticker, company, application stage, and available source context.
### Can PDUFA dates change?

Yes. FDA target action dates can move when applications, reviews, labels, or company guidance change. Use the page as a dated research aid and check source links when available.
### How is this different from LiveFeed?

The PDUFA calendar is organized by expected FDA decision date. LiveFeed is organized by newly published biotech news and company updates.