Metabolic Dysfunction-Associated Steatohepatitis
Oct 07, 2025
Aminex Therapeutics Secures FDA Orphan Drug Designation for AMXT 1501 + DFMO in Neuroblastoma; Eccogene Gets FDA Nod to Begin Phase IIa MOSAIC Trial of ECC4703 + ECC0509 in MASH; Orca Bio’s Orca-T Earns FDA Priority Review for Hematologic Malignancies; Alto Neuroscience Gains FDA Fast Track for ALTO-101 in Cognitive Impairment Linked to Schizophrenia; Taysha Gene Therapies Wins FDA Breakthrough Therapy Status for TSHA-102 in Rett Syndrome
Aminex Therapeutics Secures FDA Orphan Drug Designation for AMXT 1501 + DFMO in Neuroblastoma Aminex Therapeutics, Inc., a clinical-stage biotechnology company developing novel cancer therapies, announced that the FDA has granted Orphan Drug Designation (ODD) to AMXT 1501 in combination with difluoromethylornith...
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Aug 26, 2025
Madrigal Wins EU Approval for REZDIFFRA in MASH With Liver Fibrosis; Valneva Faces FDA License Suspension for Chikungunya Vaccine IXCHIQ; Coya Secures FDA IND Clearance for COYA 302 in ALS Treatment; Rusfertide Earns FDA Breakthrough Therapy Designation for Polycythemia Vera; Crinetics Gains FDA Orphan Drug Status for Atumelnant in Congenital Adrenal Hyperplasia
Madrigal Wins EU Approval For REZDIFFRA In MASH With Liver Fibrosis Madrigal Pharmaceuticals announced that the European Commission (EC) has granted conditional marketing authorization for REZDIFFRA, the first and only approved therapy in the European Union (EU) for adults with noncirrhotic metabolic dysfunction...
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Apr 14, 2025
Redefining Liver Disease in the Metabolic Era: From NASH to MASH and the Rise of Obesity‐targeted Therapies
The paradigm shift from Non‐alcoholic Steatohepatitis (NASH) to Metabolic Dysfunction–associated Steatohepatitis (MASH) reflects a deeper understanding of the pathophysiology underpinning liver injury in the context of obesity, diabetes, and metabolic syndrome. This evolving nomenclature from NASH to MASH is more t...
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Oct 18, 2024
From NASH to MASH: Unraveling the Evolution and Future of Liver Disease Treatment
In the ever-evolving world of liver disease, the shift from Nonalcoholic Steatohepatitis (NASH) to Metabolic Associated Steatotic Hepatitis (MASH) marks a revolutionary leap in our understanding and approach to treatment. This transition isn't merely a rebranding; it signifies a profound recognition of the intricat...
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