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The FDA on Monday only granted Liquidia’s Yutrepia tentative approval, keeping it off the U.S. market until after rival United Therapeutics’ exclusivity expires in May 2025.

After missing its Jan. 24 PDUFA date, the regulator has extended its review period but has not issued a new decision timeframe or requested additional data, Liquidia announced Thursday.

Liquidia Corporation announced that Michael Kaseta, chief operating officer and chief financial officer, will provide an update on the company’s business during a fireside chat at the BofA Securities Health Care Conference 2024 on Tuesday, May 14, 2024, beginning at 5:00 p.m.

United claims Liquidia and a former employee misappropriated its trade secrets such as regulatory submissions and detailed financial forecasts for its inhaled treprostinil.

The litigation alleges the regulator allowed its competitor Liquidia to skirt FDA precedents by amending an already pending NDA to add a PH-ILD indication instead of filing a new application.

United Therapeutics Corporation (Nasdaq: UTHR) announced today that it is pursuing additional claims for trade secret misappropriation against Liquidia Technologies, Inc.

United Therapeutics Corporation, a public benefit corporation, announced that the United States Court of Appeals for the Federal Circuit affirmed the district court decision in the patent litigation United Therapeutics brought against Liquidia Technologies, Inc.

DLA Piper represented Liquidia Technologies, Inc., a late-stage clinical biopharmaceutical company, in its acquisition of RareGen, LLC, a portfolio company of healthcare investment firm PBM Capital.

Mid-November is a relatively quiet period for the U.S. Food and Drug Administration in terms of its scheduled PDUFA dates. Read on for more.

United Therapeutics Corporation announced that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Liquidia Technologies, Inc. for infringement of the following patents relating to United Therapeutics’ product Tyvaso® Inhalation Solution: U.S. Patent Nos. 9,604,901 and 9,593,066, both of which expire in December 2028.