PDUFA calendar: selected FDA goal dates

Upcoming dates, with their source

Reviewed November 14, 2026. “Under review” means the cited sponsor document describes an application under review. It does not confirm the absence of a later announcement. Check the original source and the sponsor’s latest releases before relying on a row.

Find the relevant application

A product can have different applications and outcomes for different uses. Match product, sponsor and indication before comparing a date. Relacorilant for Cushing’s syndrome and mitapivat for sickle cell disease are specific application records here.

What this calendar tells you

A PDUFA goal date is a review milestone. It is not a prediction of approval, a promised announcement time or a commercial launch date. A missing product means it is outside this selected dataset.

Use the date-change guide to interpret revised targets and the methodology to inspect the inclusion rules. This publication is owned by Synoptic; the calendar is editorially curated from public sources.