Madrigal Pharmaceuticals
NEWS
Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) is the first-ever approved therapy for metabolic dysfunction-associated steatohepatitis—a decision experts say could signal a sea change in treatment of the disease.
The FDA’s busy week ahead involves three decision dates for potential industry firsts and a highly anticipated advisory committee meeting for two CAR-T therapies.
Madrigal Pharmaceuticals announced late-stage results published Thursday in The New England Journal of Medicine for resmetirom as it awaits a March 14 PDUFA date.
The non-alcoholic steatohepatitis space is still a “big mystery,” analysts tell BioSpace, but its connection to weight loss could provide an additional opportunity for contenders.
With Intercept’s failure to emerge as the nonalcoholic steatohepatitis market leader, Madrigal Pharmaceuticals is seeking to take leadership of the space fueled by a half-a-billion-dollar public offering.
Intercept’s failure to secure FDA approval for obeticholic acid (OCA) tablets in non-alcoholic steatohepatitis shines a light on safety challenges in the space, experts told BioSpace.
Mergers and acquisitions are expected to be a key theme in the pharmaceutical industry in 2023.
2022 featured pivotal data that could change the landscape in non-alcoholic steatohepatitis, Alzheimer’s disease, sickle cell disease and many more indications.
Madrigal’s NASH drug hits the mark in late-stage trial.
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