United Therapeutics tumbles on US FDA snub for oral PAH drug
This article was originally published in Scrip
Executive Summary
The US FDA found too many questions about United Therapeutics' oral prostacyclin vasodilator treprostinil to approve it this week as a treatment for pulmonary arterial hypertension (PAH) – issuing a complete response letter to the Silver Spring, Maryland-based company, which disclosed the disappointing news to investors after the US markets closed on 23 October.