Home/PDUFA Calendar/December 2026

Monthly PDUFA Calendar

December 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: 2026-10-08

December 2026 PDUFA milestones

This month is outside your PDUFA access window. Free includes the current month, Pro includes 3 months starting with the current month, and Ultra includes all future months. Locked dates are shown as blurred placeholders.

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December 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 December 2026 PDUFA calendar?

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