FDA Publishes Regulatory Review Period for Gilead's Livdelzi, Opens Patent Extension Comment Period
July 07, 2025
July 07, 2025
WASHINGTON, July 7 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has determined the regulatory review period for Livdelzi, a treatment for primary biliary cholangitis developed by Gilead Sciences Inc., acting as agent for Janssen Pharmaceutica N.V. This regulatory milestone sets the stage for potential extensions to several key patents covering the drug.
Livdelzi is indicated for adults with primary biliary cholangitis who have had an inade . . .
Livdelzi is indicated for adults with primary biliary cholangitis who have had an inade . . .