PDUFA History Tracker

Use the search-by-ticker tool above to pull a single company's history of FDA decision dates and the outcomes attached to each: which applications were approved and which received a Complete Response Letter. Entering a ticker returns that company's completed catalysts in one dated view, so you can see the drug, indication, and result for every past decision. For decisions a company still has ahead of it, switch to the upcoming calendar rather than this per-ticker history.

It is a record of past FDA decision deadlines and the results that followed, organized so you can retrieve a specific company's regulatory track record. A PDUFA date is the deadline by which the FDA aims to finish reviewing a new drug or biologic application, set under the Prescription Drug User Fee Act. The tracker above lets you search by ticker and study how each of a company's past decisions resolved, then move to the live calendar for any decisions still pending.

A PDUFA date is the FDA's target deadline, and the agency usually acts on or shortly before it, though a decision can slip when the FDA extends review to assess new information. Searching a ticker above lets you compare each originally scheduled deadline with the date the decision was actually announced, and those gaps reveal extensions, delays, and early actions in that company's history. The tracker records the outcome that was ultimately issued, not just the date that was first expected.

A Complete Response Letter is the FDA telling a company its application could not be approved in its then-current form, with specific deficiencies to address across manufacturing, labeling, safety, or efficacy. When you search a ticker above and see a past CRL, it is not a permanent rejection: the sponsor can fix the issues and resubmit, which starts a new review cycle and a new PDUFA date. The per-company record often shows that follow-on resubmission and, in many cases, a later approval for the same drug.

Each entry in a ticker's history above is marked by outcome, so you can scan a company's record and separate the clearances from the Complete Response Letters. Reviewing that mix gives a sense of how a sponsor's applications have fared and how its stock tended to react around each decision. This retrospective view is context for assessing similar events still ahead, not a forecast of them. This is general information, not investment advice.

Yes. A New Drug Application (NDA) covers small-molecule, chemically synthesized drugs, while a Biologics License Application (BLA) covers biologics such as antibodies, vaccines, and cell and gene therapies, and a ticker's history above can include either. Both are reviewed under the same PDUFA timelines and both resolve as an approval or a Complete Response Letter. The distinction matters when reading a company's record because biologics follow a separate regulatory pathway with different exclusivity rules.

Each company's record above is compiled from primary disclosures: FDA decision announcements, company press releases, and SEC filings, then consolidated into one dated history per ticker. Past entries are retained after a decision is issued, so a company's timeline stays auditable and you can reconstruct what was known and when. For decisions a ticker still has pending, the upcoming calendar is the place to look rather than this archive.