Vanda Pharmaceuticals, Inc.

Vanda Pharmaceuticals ’ Hetlioz (tasimelteon) cannot be approved for a new insomnia indication due to “major gaps in the evidence,” US Food and Drug Administration Acting Commissioner Sara Brenner sai

A US district court in Washington D.C. has ruled in favor of Teva in Vanda Pharmaceuticals’ bid for summary judgment arguing that the US Food and Drug Administration’s approval of Teva’s generic versi

Scrip regularly covers business development and deal making in the biopharmaceutical industry. Deal Watch is supported by deal intelligence from Biomedtracker. Novo Nordisk, IMMvention Collaboration

The US Food and Drug Administration maintained a high rate of complete response letter actions for novel agent applications in 2024, but recent history suggests that many of the 16 CRL recipients will