FDA declines to approve United-MannKind's lung disease therapy

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via The U.S. Food and Drug Administration declined to approve United Therapeutics and MannKind Corp's lung disease therapy, citing an inspection issue at a third-party facility, the companies said on Monday.

The therapy is a drug-device combination that uses United Therapeutics' approved treatment, Tyvaso, in combination with MannKind's portable inhaler.

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