
Liquidia Technologies
NEWS
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.
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.
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.
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 claims Liquidia and a former employee misappropriated its trade secrets such as regulatory submissions and detailed financial forecasts for its inhaled treprostinil.
The U.S. Food and Drug Administration (FDA) has a busy end of November planned, with numerous PDUFA dates to address. Here’s a look at the upcoming week.
Liquidia Technologies, Inc. announced the appointment of Katie Rielly-Gauvin, Vice President of Global Commercial Development at AbbVie, to the Company’s Board of Directors as a Class II director with a term expiring at the 2020 annual meeting of stockholders and to the Company’s Research and Development Committee and Nominating & Governance Committee.
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