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Tuesday, May 24, 2022

MannKind, United Therapeutics Jump as Inhaler Gets FDA Nod

 MannKind and United Therapeutics both surge after the FDA approved their Tyvaso DPI product for lung disease.

  • The FDA says that the inhaler’s potential pulmonary risks “are adequately characterized” by available data and addressed in the product’s label
    • FDA said it was approved to treat pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease in a letter rejecting a Citizen’s Petition requesting the agency not to approve the inhaler combo

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