Published on 21 Feb 2024 on Benzinga via Yahoo Finance
Wednesday, United Therapeutics Corporation (NASDAQ:UTHR) initiated legal action against the FDA, claiming that the FDA wrongly allowed Liquidia Corporation (NASDAQ:LQDA) to deviate from established rules in the drug approval process.
The litigation focuses on the FDA’s handling of Liquidia’s amendment to a pending new drug application (NDA) related to its proposed inhaled dry powder treprostinil product, seeking to add a second indication for pulmonary hypertension associated with interstitial lung disease (PH-ILD).