Yahoo Finance

Vanda Announces Bysanti™ NDA Filing; FDA Decision Expected in Early 2026

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 ...
Yahoo Finance

Vanda Seeks FDA Commissioner Review of Outgoing CDER Director's Decision to Uphold Approval of Two Generic Versions of Hetlioz®

WASHINGTON, Aug. 21, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that it has asked Martin Makary, the Commissioner of the U.S. Food and Drug Administration ...
Pharm Exec

Court Overturns FDA’s Decision to Reject Vanda Pharmaceutical’s Jet Lag Disorder Treatment

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 ...
Seeking Alpha

Vanda claims FDA 'unlawfully' delays hearing request on tradipitant decision

Vanda Pharmaceuticals (NASDAQ:VNDA) is alleging that members of the U.S. FDA "have committed to delay" its request for a hearing to discuss the agency's issuing of a Complete Response Letter in ...