PDUFA Dates: February 2027
1 FDA target action date in February 2027. Each PDUFA date is the FDA's deadline to complete review of a drug application.
A single FDA target action date this month — Zipalertinib from Cullinan Therapeutics, Inc for NSCLC with EGFR exon 20 insertion (post-platinum).
Cullinan Therapeutics, Inc. CGEM
Zipalertinib NSCLC with EGFR exon 20 insertion (post-platinum) Oncology
NDA