US FDA grants tentative approval to Liquidia's inhaled blood pressure drug

(Reuters) -The U.S. Food and Drug Administration on Monday granted a tentative approval to Liquidia Corp's drug for patients with a type of lung disorder, but stopped short of a traditional approval, sending its shares down nearly 22% before the bell.



The company said it has to wait for the expiration of regulatory exclusivity of United Therapeutics (NASDAQ:UTHR )' Tyvaso on May 23, 2025 before final approval can be granted.

The company said it will challenge the FDA's decision to grant regulatory exclusivity to United's Tyvaso.

Source: Investing.com