# BioPharmSignal PDUFA Calendar

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

BioPharmSignal PDUFA Calendar tracks upcoming FDA target action dates and regulatory decision milestones for biotech and pharma companies.

## How To Use The Calendar

- Search by ticker to narrow the month.
- Review the date, company, stage, status, and milestone summary.
- Open the company page or source URL when more context is available.
- Pair the calendar with LiveFeed to see whether news is changing the setup before the FDA date.

## Current Month Events (2026-07)

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