Home/PDUFA Calendar/August 2026

Monthly PDUFA Calendar

August 2026 PDUFA Calendar: FDA Decision Dates & Biotech Catalysts

This monthly PDUFA calendar lists active FDA target action dates and biotech regulatory decision milestones tracked by BioPharmSignal. Use it to scan which tickers have NDA or BLA events, then open the company page for surrounding news and stock context.

Last updated: 2026-08-20

August 2026 PDUFA milestones

Calendar view

August 2026

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How to use this month page

Start with the event date, then check the ticker and stage. A BLA event usually relates to a biologic application, while an NDA event usually relates to a new drug application. The company page helps connect the date with recent news flow.

Frequently asked questions

What is listed on the August 2026 PDUFA calendar?

This page lists active BioPharmSignal PDUFA and FDA decision milestones dated in August 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.