Get started

Top lists · Biotech and FDA catalysts

Latest PDUFA date announcements

Quantisnow recorded 5 PDUFA date announcements in the last 60 days across 5 companies.

Releases that set, move or mention an FDA PDUFA action date.

Events
5
Companies
5
Busiest day
Oct 30
1 that day
Most frequent
AGIO
1 events

Most frequent tickers

Newest first

  1. 01AGIO
    Agios Announces New PDUFA Goal Date of February 1, 2027, for Mitapivat Sickle Cell Disease sNDA; Company Is Launch-Ready and in Labeling Discussions with FDA
  2. 02PVLA
    Palvella Announces FDA Acceptance and Priority Review of QTORIN™ Rapamycin NDA; February 28, 2027 PDUFA Target Action Date Set
  3. 03UNCY
    Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate New Drug Application Resubmission and PDUFA Date of March 25, 2027
  4. 04AQST
    Aquestive Therapeutics Announces FDA Acceptance of Anaphylm™ NDA Resubmission and PDUFA Goal Date of March 16, 2027
  5. 05INSM
    FDA Grants Priority Review to Insmed's sNDA for ARIKAYCE® (amikacin liposome inhalation suspension) for Treatment of MAC Lung Disease With PDUFA Target Action Date Set for January 28, 2027

Monthly archive

Questions

How many PDUFA date announcements were there in the last 60 days?
Quantisnow recorded 5 PDUFA date announcements in the last 60 days across 5 companies.
What is a PDUFA date?
It is the target date by which the FDA aims to act on a drug or biologic application, set under the Prescription Drug User Fee Act. Approval or a complete response letter typically arrives on or shortly before that date.

Related lists

Learn more