FDA balks at standard approval of Liquidia's PAH rival to United's Tyvaso after lengthy court saga
Fierce Pharma
AUGUST 19, 2024
Liquidia and its dry powder Yutrepia is back in FDA limbo after the agency opted for a tentative approval as opposed to a standard nod. | The agency granted a broad regulatory exclusivity to rival United Therapeutics and its Tyvasvo DPI, leaving Liquidia's Yutrepia, which uses the same active drug, in FDA limbo until 2025.
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