News & Updates

New drug applications approved by US FDA as of 16-30 November  2023 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Histological disease progression in patients with nonalcoholic fatty liver disease (NAFLD) is significantly associated with a higher rate of developing incident end-stage liver disease (ESLD) but not with all-cause mortality, a study has shown.

Treatment with resmetirom significantly reduced low-density lipoprotein cholesterol (LDL-C) and other atherogenic lipids, as well as restored thyroid hormone (TH) levels in patients with nonalcoholic steatohepatitis (NASH), according to two subgroup analyses of the MAESTRO-NASH trial presented at The Liver Meeting 2023.

Treatment with seladelpar significantly improves serum markers of cholestasis, including alkaline phosphatase (ALP) and total bilirubin (TB), and reduces pruritus in patients with primary biliary cholangitis (PBC) who are at risk for disease progression, according to the RESPONSE trial presented at The Liver Meeting 2023.

The oral, dual peroxisome proliferator-activated receptor-α/δ agonist elafibranor improves biomarkers of cholestasis and quells itching in patients with primary biliary cholangitis, while having an acceptable safety profile, as shown in the phase III ELATIVE study.

Long-term monthly treatment with givosiran has good tolerability and offers continuous improvements to patients with acute hepatic porphyria (AHP), results of the phase III ENVISION trial have shown.