FDA Drug Approval Calendar

The PDUFA date (Prescription Drug User Fee Act) is the FDA’s target deadline to approve or reject a New Drug Application (NDA) or Biologics License Application (BLA). These are major catalysts for biotech stocks, as a decision often triggers significant price movement.

This column shows the current stage or outcome of the FDA-related event listed, such as PDUFA Target Date Set, CRL Issued, Approved, or Designation Granted. It gives you a quick snapshot of where the drug is in the regulatory process and what action has occurred (or is expected).

Phase 1: Focuses on safety and dosage in a small group of healthy volunteers.

Phase 2: Explores effectiveness and side effects in a larger patient group.

Phase 3: Confirms effectiveness, monitors side effects, and compares with standard treatments in large populations. This is usually the last step before FDA submission.

Submission means the company has filed an NDA or BLA with the FDA. Review is the FDA’s evaluation period leading up to the PDUFA date. Approval indicates the FDA has given the green light to market the drug.

A grant refers to an award of a designation (i.e., RMAT), while a target date usually refers to a PDUFA date (the FDA’s deadline to act on an NDA or BLA).

Special FDA designations are programs designed to expedite the development and review of promising therapies. Breakthrough Therapy designation is granted to drugs that may offer substantial improvement over existing treatments for serious conditions. Orphan Drug designation is awarded to treatments targeting rare diseases affecting fewer than 200,000 people in the U.S. Other fast-track designations include RMAT (Regenerative Medicine Advanced Therapy), Fast Track, and Accelerated Approval.

Yes, you can export the data to Excel for further sorting, filtering, or integration into personal analytics tools.