PDUFA Calendar 2026

A PDUFA date is the deadline by which the FDA aims to complete its review of a new drug or biologic application and issue a decision. The name comes from the Prescription Drug User Fee Act, the law that lets the FDA collect fees from drug makers in exchange for committing to these review timelines. On or before the PDUFA date the FDA will approve the drug, issue a Complete Response Letter, or otherwise act on the application. Because these dates are binary events, they are among the most watched catalysts for biotech stocks, and upcoming ones are listed on the calendar above.

The PDUFA calendar above can be sorted by date to show decisions expected this week or over the next five trading days, including small-cap biotech catalysts. Each entry lists the company, drug, indication, and expected decision date so you can scan what is coming at a glance. Because the FDA can act a few days before a listed PDUFA date, watch the days leading up to each event, not only the date itself.

No. The FDA does not publish a public, forward-looking calendar of pending PDUFA dates, because confidentiality rules (21 CFR 314.430) generally bar it from confirming that an application even exists until the sponsor makes it public. The PDUFA dates you see come from the drug companies themselves, who disclose expected action dates in press releases and SEC filings, and from aggregators that compile and verify them. The PDUFA calendar on this page is one such aggregated, regularly updated source.

The FDA issues its decision on or before the PDUFA date, so an approval or rejection can come a few days early rather than exactly on the listed date. There is no fixed announcement time: decisions are often disclosed after the market closes or in the pre-market hours, frequently through a company press release rather than an FDA notice. Because the timing is unpredictable, traders track both the date itself and the days immediately before it.

A Complete Response Letter is the FDA's way of telling a drug company that its application cannot be approved in its current form. The letter spells out the deficiencies the company must address, which can range from manufacturing and labeling issues to questions about safety or effectiveness. A CRL is not a permanent rejection: the sponsor can fix the problems and resubmit, which starts a new review cycle and a new PDUFA date. CRLs often trigger sharp stock declines because they delay or jeopardize a product launch.

An AdCom date is when an outside expert panel meets to review a drug's data and cast a non-binding vote, usually several months before the final decision. The PDUFA date is the FDA's own deadline to act on the application, when the actual approval or Complete Response Letter is issued. A drug may have both an AdCom date and a PDUFA date, and both appear as separate catalysts on the calendar above.

A New Drug Application (NDA) is the submission used to seek approval for small-molecule, chemically synthesized drugs, while a Biologics License Application (BLA) covers biologics such as antibodies, vaccines, and cell and gene therapies. Both are reviewed under the same PDUFA timelines and both result in either approval or a Complete Response Letter. The distinction matters because biologics follow a separate regulatory pathway and have different exclusivity rules.