PDUFA Dates: February 2027

2 FDA target action dates in February 2027. Each PDUFA date is the FDA's deadline to complete review of a drug application.

Mix: 1 NDA, 1 unspecified. Therapeutic areas: oncology.

← January 2027 Full Calendar March 2027 →

Cullinan Therapeutics, Inc. CGEM

Zipalertinib

NSCLC with EGFR exon 20 insertion (post-platinum) Oncology

NDA

Feb 27, 2027

105 days

PALVELLA THERAPEUTICS, INC. PVLA

QTORIN 0

Feb 28, 2027

106 days

← January 2027 March 2027 →

All PDUFA Months

May 2026 (5) June 2026 (16) July 2026 (8) August 2026 (16) September 2026 (14) October 2026 (9) November 2026 (14) December 2026 (9) January 2027 (5) February 2027 (2) March 2027 (2) April 2027 (1) May 2027 (2) August 2027 (1)