December 2026 PDUFA dates: selected applications

Selected December goal dates

The source date shows when the sponsor disclosed the cited information. November 14 is the editorial review date for this pilot.

Read the indication before the product name

Corcept’s relacorilant record concerns Cushing’s syndrome. Hansa’s imlifidase milestone concerns U.S. kidney transplant desensitization. Praxis’s relutrigine record concerns SCN2A and SCN8A developmental and epileptic encephalopathies.

A search result for the same active ingredient in another disease or jurisdiction cannot resolve these applications. Save the specific use alongside the source URL.

Use a dated review note

For each monitored application, record when you checked the latest sponsor announcement and the original source’s publication date. If the date changes, add a new dated observation and keep the previous record. Do not rewrite the old source as if it contained the new target.

See how dates change for the evidence required before changing a calendar row.