Madrigal Pharmaceuticals
NEWS
While Madrigal Pharmaceuticals secured the first FDA drug approval for metabolic dysfunction–associated steatohepatitis, Akero Therapeutics is developing what may serve as a viable alternative treatment for precirrhotic disease.
With its FDA approval last week and first-to-market advantage, Madrigal Pharmaceuticals’ Rezdiffra will set the standard for other metabolic dysfunction-associated steatohepatitis candidates in development.
If you’re confused by the NASH versus MASH indication, you’re not alone.
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.
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