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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 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.
(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 ...
Aramchol is an investigational drug being developed by Galmed Pharmaceuticals as a first-in-class, potentially disease modifying treatment for nonalcoholic steatohepatitis, or NASH, a more advanced condition of non-alcoholic fatty liver disease. [1] [2] [3] [4]
Non-alcoholic steatohepatitis is a common cause of abnormal liver function with histological features of fatty liver, inflammation and fibrosis. It may progress to cirrhosis and is becoming an increasing indication for liver transplantation. It is increasing in prevalence. OCA is proposed to treat NASH. [21]
The rejection marks Intercept's second failed attempt at securing approval for the drug to treat patients with non-alcoholic steatohepatitis (NASH) - a liver disease that affects 5% of U.S. adults ...
Volixibat (INN; [1] development code SHP626) is a medication under development as a possible treatment for nonalcoholic steatohepatitis (NASH), the most severe form of non-alcoholic fatty liver disease (NAFLD). No other pharmacotherapy yet exists for NASH, so there is interest in whether volixibat can prove to be both safe and effective.
(Reuters) -The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences' liver disease treatment, Livdelzi, which it gained through a $4.3 billion buyout of CymaBay Therapeutics ...
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