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Original New Drug Application Approvals by US FDA (16-30 November 2023)

13 Dec 2023

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.

Original New Drug Application Approvals by US FDA (16-30 November 2023)

13 Dec 2023

AFP-L3, DCP predict HCC recurrence after liver transplant

13 Dec 2023

Dual positivity for alpha-fetoprotein (AFP) bound to Lens culinaris agglutinin (AFP-L3) ≥15 percent and des-gamma-carboxyprothrombin (DCP) ≥7.5 can strongly predict majority of early hepatocellular carcinoma (HCC) recurrences following liver transplantation (LT), suggests a study.

AFP-L3, DCP predict HCC recurrence after liver transplant

13 Dec 2023

NAFLD progression may raise ESLD risk

13 Dec 2023

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.

NAFLD progression may raise ESLD risk

13 Dec 2023

Molecular-based guided therapy shows promise in treatment-resistant HCC/H-CCK

12 Dec 2023

A recent study has demonstrated the feasibility of molecular-based targeted therapy in patients with hepatocellular carcinoma (HCC)/hepato-cholangiocarcinoma (H-CCK) that progressed while under treatment with atezolizumab/bevacizumab.

Molecular-based guided therapy shows promise in treatment-resistant HCC/H-CCK

12 Dec 2023

Resmetirom reduces bad cholesterol, restores thyroid hormones in NASH

12 Dec 2023 bởi

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.

Resmetirom reduces bad cholesterol, restores thyroid hormones in NASH

12 Dec 2023

Gestational diabetes history ups NAFLD risk in women

04 Dec 2023

Women with a history of gestational diabetes mellitus (GDM) are at higher risk of developing nonalcoholic fatty liver disease (NAFLD), suggests a recent study.

Gestational diabetes history ups NAFLD risk in women

04 Dec 2023

Seladelpar improves markers of cholestasis, reduces pruritus in patients with PBC

01 Dec 2023 bởi

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.

Seladelpar improves markers of cholestasis, reduces pruritus in patients with PBC

01 Dec 2023

Hepatocellular carcinoma risk diminishes with time following HCV eradication

30 Nov 2023

Among individuals with cirrhosis and cured hepatitis C virus (HCV) infection, the risk of hepatocellular carcinoma tapers off progressively through 6 years after HCV eradication, as shown in a study. However, the risk remains above thresholds that require screening.

Hepatocellular carcinoma risk diminishes with time following HCV eradication

30 Nov 2023

Elafibranor for primary biliary cholangitis scores high in phase III trial

29 Nov 2023 bởi

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.

Elafibranor for primary biliary cholangitis scores high in phase III trial

29 Nov 2023

Givosiran delivers safe, sustained improvements in acute hepatic porphyria

28 Nov 2023 bởi

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.

Givosiran delivers safe, sustained improvements in acute hepatic porphyria

28 Nov 2023

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Original New Drug Application Approvals by US FDA (16-30 November 2023)

Original New Drug Application Approvals by US FDA (16-30 November 2023)

AFP-L3, DCP predict HCC recurrence after liver transplant

AFP-L3, DCP predict HCC recurrence after liver transplant

NAFLD progression may raise ESLD risk

NAFLD progression may raise ESLD risk

Molecular-based guided therapy shows promise in treatment-resistant HCC/H-CCK

Molecular-based guided therapy shows promise in treatment-resistant HCC/H-CCK

Resmetirom reduces bad cholesterol, restores thyroid hormones in NASH

Resmetirom reduces bad cholesterol, restores thyroid hormones in NASH

Gestational diabetes history ups NAFLD risk in women

Gestational diabetes history ups NAFLD risk in women

Seladelpar improves markers of cholestasis, reduces pruritus in patients with PBC

Seladelpar improves markers of cholestasis, reduces pruritus in patients with PBC

Hepatocellular carcinoma risk diminishes with time following HCV eradication

Hepatocellular carcinoma risk diminishes with time following HCV eradication

Elafibranor for primary biliary cholangitis scores high in phase III trial

Elafibranor for primary biliary cholangitis scores high in phase III trial

Givosiran delivers safe, sustained improvements in acute hepatic porphyria

Givosiran delivers safe, sustained improvements in acute hepatic porphyria