PDUFA Dates: January 2026

2 FDA target action dates in January 2026. Each PDUFA date is the FDA's deadline to complete review of a drug application.

Mix: 1 NDA, 1 unspecified.

Full Calendar February 2026 →

Aquestive Therapeutics, Inc. AQST

Anaphylm (dibutepinephrine sublingual film)

Type I allergic reactions (anaphylaxis)

NDA

Jan 31, 2026

168 days ago

Pharming Group N.V. PHAR

0

Jan 31, 2026

168 days ago

February 2026 →

All PDUFA Months

January 2026 (2) February 2026 (4) March 2026 (8) April 2026 (6) May 2026 (6) June 2026 (18) July 2026 (8) August 2026 (9) September 2026 (6) October 2026 (6) November 2026 (4) December 2026 (9) January 2027 (1) February 2027 (1)