PDUFA Dates December 2026

A PDUFA date is the FDA’s target deadline to complete its review of a drug application under the Prescription Drug User Fee Act. Approval, a Complete Response Letter, or a delay on this date is one of the largest single-day catalysts a biotech stock has. Dates below are extracted from company 8-K filings and official notices, with the source linked on every event.

• PDUFA decision MLYS Mineralys Therapeutics, Inc. PDUFA target action date: Mineralys Therapeutics, Inc. 2026-12-22
• PDUFA decision VTRS Viatris Inc. PDUFA target action date: Viatris Inc. 2026-12-27