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(Reuters) -The U.S. FDA has approved Madrigal Pharmaceuticals' drug for a fatty liver disease known as non-alcoholic steatohepatitis (NASH), the first treatment to get the nod for the condition ...
The US Food and Drug Administration has approved the first medication for a common form of liver inflammation called nonalcoholic steatohepatitis, or NASH, the agency said Thursday.. NASH — also ...
(Reuters) -Madrigal Pharmaceuticals shares jumped as much as 23% on Friday after its oral drug became the first approved treatment for a fatty liver disease known as non-alcoholic steatohepatitis ...
The US Food and Drug Administration (FDA) evaluated the safety and efficacy of resmetirom based on an analysis of a surrogate endpoint at month twelve in a 54-month, randomized, double-blind placebo-controlled trial. [2] The surrogate endpoint measured the extent of liver inflammation and scarring. [2]
The U.S. Food and Drug Administration (FDA) approved obeticholic acid on 27 May 2016, for the treatment of primary biliary cholangitis. It was approved as an orphan drug based on its reduction in the level of the biomarker alkaline phosphatase as a surrogate endpoint for clinical benefit. [12]
To encourage development and testing, the U.S. Food and Drug Administration (FDA) has issued fast track status. [ 2 ] Volixibat is an IBAT inhibitor, meaning that it blocks the function of the IBAT protein (ileal bile acid transporter), which is also called SLC10A2 (solute carrier family 10 member 2) or ASBT (apical sodium–bile acid transporter).
In March 2024, the U.S. Food and Drug Administration (FDA) approved resmetirom — sold under the brand name Rezdiffra® — for people with NASH and moderate to advanced liver scarring.
Intercept Pharmaceuticals, Inc. is an American biopharmaceutical company incorporated in 2002, focusing on the development of novel synthetic bile acid analogs to treat chronic liver diseases, such as primary biliary cirrhosis (PBC) now called primary biliary cholangitis, non-alcoholic fatty liver disease (or non-alcoholic steatohepatitis, NASH), cirrhosis, portal hypertension, primary ...
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