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United Therapeutics Announces FDA Acceptance Of SNDA For Nebulized Tyvaso In IPF

Source: Nasdaq

Healthcare & BiotechRegulation & LegislationProduct LaunchesCompany Fundamentals

United Therapeutics (UTHR) said the U.S. FDA accepted its supplemental New Drug Application for nebulized Tyvaso Inhalation Solution to treat idiopathic pulmonary fibrosis. The FDA acceptance is a positive regulatory milestone that can support the program’s path forward, though it does not yet imply approval.

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