BiopharmaWatch FDA Calendar Guide: Track Every Biotech Catalyst and PDUFA Date in Real Time

A PDUFA date is the deadline the FDA sets itself to decide on a drug application. It is the single most tradeable date in biotech, and it is also the most widely misunderstood. This guide explains what the date is, what actually happens around it, and how to track the full calendar without missing the decisions that move a stock.

Last reviewed 26 August 2026. The decision table below is drawn from the BiopharmaWatch FDA calendar and covers confirmed PDUFA goal dates through the end of October 2026.

What a PDUFA date actually is

Under the Prescription Drug User Fee Act, a company pays a fee when it files a New Drug Application (NDA) or Biologics License Application (BLA), and in exchange the FDA commits to a review clock. A standard review runs about ten months from the filing acceptance, and a priority review runs about six. The date at the end of that clock is the PDUFA date.

The critical point for investors: a PDUFA date is a deadline, not an appointment. The FDA can and regularly does act early. In May 2026 the agency approved ENHERTU for two new early breast cancer indications fifty-three days before its scheduled July goal date. Anyone watching only the calendar entry would have learned about the approval almost two months late.

The four outcomes to plan for

Approval. The drug is cleared, usually with a specific label. The label wording matters as much as the approval: a narrower indication than expected can send a stock down on an approval.

Complete Response Letter (CRL). The FDA declines to approve in this cycle and sets out what is missing. A CRL is not the end of a program. The company can resubmit, and a resubmission restarts a shorter review clock, so a CRL creates a second dated catalyst rather than closing the story.

Extension. If the company submits substantial new information, the FDA can treat it as a major amendment and push the goal date out, typically by three months. The old date passes with no news, which is itself information.

Silence. The date passes and nothing is announced. Foreign private issuers file no 8-K, so a decision can be public in a company press release days before it reaches any SEC feed.

The PDUFA calendar right now

Below are the confirmed FDA decision dates between now and the end of October 2026. Each drug is listed against the company whose application it is, which matters more than it sounds: a drug developed by one company and commercialised by a partner is frequently filed under the wrong ticker elsewhere, and a calendar that gets the sponsor wrong will point you at the wrong stock.

This is the next two months only. The full list, including advisory committee meetings, late-stage readouts and supplemental filings, sits on the FDA calendar, and decision dates alone are on the PDUFA calendar. For a month-by-month write-up see FDA Calendar August 2026 and FDA Calendar July 2026.

What belongs on a complete catalyst calendar

PDUFA dates are only one class of dated event. A calendar that tracks only them will miss most of the moves. The others worth tracking are advisory committee (AdCom) meetings, which are scheduled ahead of the decision and often move a stock more than the approval itself; late-stage data readouts, where the company guides to a quarter or a half rather than a day; and label expansions filed as supplemental applications, which carry their own review clocks.

How to use the BiopharmaWatch calendar

Our FDA calendar tracks upcoming decisions across the listed biotech and pharma universe, with the drug, the indication, the sponsor and the stage attached to each date. The PDUFA calendar narrows that to regulatory decision dates specifically, and the historical view keeps every past decision with its outcome so a date can be checked after the fact rather than disappearing once it passes.

Each entry carries the evidence behind it, so a date can be traced to the filing or announcement it came from. Dates are revised as companies update guidance, and the prior version is kept rather than overwritten, which is what makes it possible to ask what was known on a given day.

What to do when a date moves

Goal dates are revised more often than most calendars admit. A company submits new data, the FDA classifies it as a major amendment, and the clock extends, usually by three months. Sometimes the change is smaller: a readout guided to a quarter gets pinned to a day, or a day slips back to a quarter as enrolment runs long.

The trap is that a revision can leave two live entries behind, the old date and the new one, if whoever maintains the calendar adds the new date without retiring the old. You then see the same drug twice with two different dates, and often two different probability figures, which is a reliable sign the source is adding rather than superseding. When you meet a duplicate like that, trust the entry that carries the more recent supporting filing, and treat the older one as void.

On BiopharmaWatch a revised date supersedes the previous one rather than overwriting it, so the earlier version stays queryable. That is what makes it possible to ask what the calendar said on a given day, which is the only honest way to check whether a catalyst was actually knowable before a move.

Three habits that separate good catalyst tracking from bad

Watch the window, not the day. Because the agency can act early, treat a PDUFA date as the far end of a range that opens weeks before it.

Read the label, not the headline. The commercial value of an approval sits in the indication wording and any boxed warning, neither of which appears in the first alert.

Track resubmissions. A CRL cycle is where expectations reset hardest, and it is the part of the calendar most often dropped after the first bad headline.

Start with the FDA calendar for the full picture, or go straight to the PDUFA calendar if you are tracking decision dates only.