WASHINGTON, May 5, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) informed Vanda that the New Drug Application ...
The FDA's decision on Hetlioz for jet lag disorder cites insufficient evidence despite positive efficacy signals from clinical trials. Legal proceedings previously criticized the FDA's review, leading ...
Vanda Pharmaceuticals won a legal battle as a federal court overturned the FDA's rejection of Hetlioz for jet lag disorder, highlighting the court's support for Vanda's evidence. The court criticized ...