United Therapeutics' PAH drug Tyvaso faces US delay
This article was originally published in Scrip
Executive Summary
United Therapeutics' Tyvaso, an inhaled formulation of treprostinil for pulmonary arterial hypertension (PAH), is facing an approval delay in the US after the FDA asked questions relating to instructions for using the portable nebuliser that delivers the drug, which will require the company to conduct an additional study.