News about tradipitant fda approval

Here is some news about Tradipitant's FDA approval process:

1. FDA Acceptance of NDA: Vanda Pharmaceuticals' NDA for Tradipitant was accepted by the FDA, setting a PDUFA date of September 18, 2024, for the decision on its approval for gastroparesis.
2. Market Potential: The global gastroparesis treatment market is projected to reach $7.19 billion by 2029, indicating a significant market potential for Tradipitant if approved.
3. Clinical Trials: Tradipitant has shown efficacy in reducing nausea and other symptoms of gastroparesis in Phase II and III clinical trials.
4. Expanded Access: The FDA has authorized expanded access to Tradipitant for a single patient with gastroparesis, allowing continued treatment beyond the 12-week trial period.
5. Other Developments: Vanda is also exploring Tradipitant's potential for motion sickness and atopic dermatitis, in addition to its development for gastroparesis.

In summary, Tradipitant's FDA approval for gastroparesis is still pending, with a decision expected on September 18, 2024. However, the drug has shown promise in clinical trials, and its potential market is significant if approved.