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The FDA has issued a complete response to United Therapeutics Corporation (NASDAQ: UTHR) regarding the marketing application for Tyvaso DPI for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA’s letter noted only a single deficiency related to an open inspection issue at a third-party facility that performs analytical testing of the treprostinil drug substance.
...read full article on Benzinga
