FDA Calendar 2026 Upcoming FDA Approval Dates & PDUFA Dates

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 calendar above can be sorted by date so you can see decisions expected in the current week or over the next five trading days, including small-cap biotech catalysts. Recently issued approvals and Complete Response Letters are listed alongside upcoming dates, so you can review both what just happened and what is coming next. Because the FDA can act a few days before a listed PDUFA date, it is worth watching the days leading up to each event, not just 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 in calendars 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 calendar on this page is one such aggregated, regularly updated source.

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 Advisory Committee, or AdCom, is a panel of outside experts the FDA convenes to review a drug's data and vote on questions about its safety and efficacy. The vote is non-binding, but the FDA usually follows the panel's recommendation, so the outcome is a major catalyst. AdComs typically take place several months before the PDUFA date and can move a stock sharply in either direction on the day of the vote. Scheduled AdCom dates appear alongside PDUFA dates 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.

After Phase 3 trials finish, a company typically needs 6 to 12 months to compile and submit the New Drug Application (NDA) or Biologics License Application (BLA). The FDA then takes about 60 days to decide whether to accept the filing, after which the formal review clock runs 10 months for a standard review or 6 months for a priority review. In total, the path from Phase 3 completion to an FDA decision often spans roughly a year and a half to two years, though it varies widely by program and review type. Each application's specific PDUFA decision date appears on the calendar above once it is set.