US FDA September User Fee Calendar Slims Down, Still Boasts More Than Five Novel Agents

New therapies in the wings include two candidates for Niemman-Pick disease type C, a first-in-class antipsychotic, a targeted oncology therapy under Real-Time Oncology Review, and a new drug for gastroparesis.

September goals
September likely will not be as busy with FDA approvals as August. • Source: Shutterstock

The US Food and Drug Administration’s September will probably look quiet after August 2024 produced seven novel approvals and two complete response letters, but should still be interesting. As many as seven novel agents could see an FDA decision in September, the Pink Sheet US FDA Performance Tracker’s User Fee Goal Dates tracker shows.

Key Takeaways
  • Five novel agents are known to have been assigned September 2024 user fee goal dates and two more could see action in the month.

  • The FDA’s September 2024 novel approval count probably will not match the seven novel agents cleared in August

The novel agents in line for near-term FDA action are slightly weighted toward orphan diseases, including two candidates for the lysosomal storage disorder Niemann-Pick disease type C (NPC) and a rare subset of

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