What does PDUFA stand for?

The Prescription Drug User Fee Act, the US law under which drug companies pay fees for FDA reviews and the FDA sets target dates for its decisions.

What is the difference between an NDA and a BLA?

A New Drug Application (NDA) asks the FDA to approve a conventional, chemically made drug; a Biologics License Application (BLA) covers biologics such as vaccines, antibodies and other products made from living cells. A supplemental application asks to change an approved product, for example to add a new use.

What is priority review?

A faster FDA review for drugs that could be a significant improvement in treating a serious condition, so the decision date comes sooner than in a standard review.

Does the FDA always decide on the PDUFA date?

Not always. The FDA can act before it, and the date can be pushed back, for example when the review is extended.

Is the PDUFA list free?

Members of any Premium plan see the full list. Everyone else sees a preview of 10 rows with the date, drug and notes hidden.

Feature guide · Updated November 11, 2026

PDUFA Dates

A PDUFA date is the FDA's target date for deciding on a drug or biologic application. Our PDUFA Dates list shows the upcoming ones we track for US-listed companies, earliest first, with the drug, the type of application and where the date came from.

Open PDUFA Dates

1 · What it is

What is a PDUFA date?

When a company asks the US Food and Drug Administration (FDA) to approve a new drug or biologic, the FDA sets a target date for its decision under the Prescription Drug User Fee Act (PDUFA). That is the PDUFA date. An approval or a rejection can move a small biotech company's stock a lot, so investors watch these dates. The PDUFA Dates list shows the upcoming PDUFA dates we track for US-listed companies, earliest first.

2 · How we build it

How we build the list

From company announcements. Our data team enters PDUFA dates, and software reads new company press releases for them. Rows link to the press release or source the date came from.
Upcoming dates only. The list starts from the current trading day; once a date has passed it drops off. Decisions and outcomes are not shown.
Rough dates. When a company has given only a quarter, a half or a year, the Date column shows that period, such as Q4 or FY, and the list sorts it at the end of the period.
What each row shows. The stock, the company's market cap, the date, the status (a New Drug Application or Biologics License Application, supplemental or under Priority Review), a short drug description and notes.
Updates. The list is rebuilt about every 5 minutes.

The list shows the PDUFA dates we track, not every one: not every company publishes its dates, and a date shows only for stocks we have daily market data for. The FDA can act before a PDUFA date, and the date can move.

3 · Questions it answers

What you can find out

Which biotech stocks have FDA decision dates coming up?

The list is sorted by date, earliest first, 50 to a page. Premium members can narrow it to their watchlist, an ETF's holdings, a sector or industry, a market cap range, or stocks with listed options. See upcoming PDUFA dates

When is the FDA expected to decide on a company's drug?

Premium members can search the list by symbol, company, drug or notes to find the row, with its date and the press release it came from. Search the PDUFA list

Is it a new drug or a biologic, and is it under priority review?

The Status column shows the type of application - New Drug Application or Biologics License Application, and whether it is supplemental - and Priority Review when the FDA granted one. Premium members can filter by status. See the status of each application

What other events are coming up for biotech stocks?

The Company Events calendar can also show FDA advisory committee meetings, clinical trial events and data presentations, and the Biotech Stock Catalysts report puts clinical trial dates, biotech and healthcare company events and PDUFA dates next to the options' implied moves. How the Company Events calendar works

4 · Where to find it

Where to find it

Menu: Stocks › For Premium Users › Reports › PDUFA Dates, or go straight to /PDUFA-Dates.

SymbolCompany NameMarket CapDateStatusDrug DescriptionPress Release or LinkNotes

Date - the PDUFA date, or the quarter, half or year the company gave.

Status - the type of application and any priority review.

Press Release or Link - where the date came from.

Members of any Premium plan see the full list and its filters. Everyone else sees a preview of 10 rows with the symbol, company, market cap and status, and the date, drug, notes and link hidden.

FAQ

What does PDUFA stand for?: The Prescription Drug User Fee Act, the US law under which drug companies pay fees for FDA reviews and the FDA sets target dates for its decisions.
What is the difference between an NDA and a BLA?: A New Drug Application (NDA) asks the FDA to approve a conventional, chemically made drug; a Biologics License Application (BLA) covers biologics such as vaccines, antibodies and other products made from living cells. A supplemental application asks to change an approved product, for example to add a new use.
What is priority review?: A faster FDA review for drugs that could be a significant improvement in treating a serious condition, so the decision date comes sooner than in a standard review.
Does the FDA always decide on the PDUFA date?: Not always. The FDA can act before it, and the date can be pushed back, for example when the review is extended.
Is the PDUFA list free?: Members of any Premium plan see the full list. Everyone else sees a preview of 10 rows with the date, drug and notes hidden.

Company Events Calendar Biotech Stock Catalysts Analyzing unusual options activity

Terms on this page

PDUFA date Priority review New Drug Application Biologics License Application

Market Chameleon provides data, not investment advice.