Liquidia has filed a legal challenge to the U.S. Food and Drug Administration’s decision to grant a three-year exclusivity to United Therapeutics’ inhaled drug used to treat lung disorders, the drugmaker said on Thursday.
The FDA on Monday only granted Liquida’s Yutrepia tentative approval, keeping it off the U.S. market until after rival United Therapeutics’ exclusivity expires in May 2025.
BioNTech on Monday said the U.S. Food and Drug Administration (FDA) has lifted a partial clinical hold on an early stage study of its experimental cancer drug.
Sarepta Therapeutics’ gene therapy Elevidys will be available to Duchenne muscular dystrophy (DMD) patients who are at least 4 years old, regardless of whether they can walk, the FDA said Thursday.
PTC Therapeutics announced Thursday that its Huntington’s disease candidate PTC518 is no longer subject to an FDA partial clinical hold after it showed positive interim results from a Phase II study.
AstraZeneca announced Monday that it has secured FDA approval for an add-on to its blockbuster rare disease franchise, providing a potential differentiator as it tries to hold off competition from Novartis, Roche, and biosimilars.
ReutersThe U.S. Food and Drug Administration on Wednesday approved Johnson & Johnson unit Actelion Pharmaceuticals’ injection, making it the first-ever treatment to treat severe frostbite in adults.
The FDA on Tuesday approved Ipsen’s Onivyde, when used in combination with three chemotherapeutic drugs, for the treatment of newly diagnosed patients with metastatic pancreatic adenocarcinoma.
Zealand Pharma said on Saturday that the U.S. Food and Drug Administration (FDA) had declined to approve its drug for preventing and treating low blood sugar in children with a genetic disorder after finding deficiencies at a third-party manufacturing facility.
Advisers to the U.S. Food and Drug Administration on Thursday will discuss and vote on whether to recommend targeting one of the currently dominant XBB coronavirus variants in updated COVID-19 shots being developed for a fall vaccination campaign.