FDA Priority Review Likely for Tyvaso DPI, Inhaled Treprostinil for PAH

FDA Priority Review Likely for Tyvaso DPI, Inhaled Treprostinil for PAH

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FDA Priority Review Likely for Tyvaso DPI, Inhaled Treprostinil for PAH

United Therapeutics is planning to ask the U.S. Food and Drug Administration (FDA) for an accelerated review of Tyvaso DPI, an investigational therapy-inhaler device treatment for two forms of pulmonary hypertension, in an approval request it expects to file by midyear. The request, in the form of a new drug application to the agency, will make use of a rare pediatric disease priority review voucher that United Therapeutics paid $105 million to acquire under a recent definitive purchase agreement,…

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