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The FDA clearance sets Novo’s medicine up for a market battle with Madrigal Pharmaceuticals’ fast-selling Rezdiffra.
Novo Nordisk’s GLP-1 drug Wegovy expanded its label to include the metabolic disorder known as MASH. Analysts say there’s ...
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Pharmaceutical Technology on MSNWegovy becomes first GLP-1RA to gain FDA MASH approval
Novo Nordisk's Wegovy has received accelerated approval for use in patients with metabolic dysfunction-associated ...
On Friday, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) had approved Wegovy for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). Wegovy has become a ...
Madrigal Pharmaceuticals, Inc.'s Rezdiffra saw Q2 net sales soar 55% to $212.8M amid strong growth. EU approval expected by ...
Rezdiffra is the first and only medication approved for people living with MASH in the European Union Conditional marketing authorization is based on positive results from the pivotal Phase 3 ...
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today announced that it ...
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Pharmaceutical Technology on MSNMadrigal wins European MASH approval as Novo rivalry looms
"Madrigal wins European MASH approval as Novo rivalry looms" was originally created and published by Pharmaceutical ...
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Zacks Investment Research on MSNMadrigal Gets Conditional Nod for MASH Drug Rezdiffra in EU
Madrigal Pharmaceuticals MDGL announced that the European Commission (EC) has granted a conditional marketing authorization ...
Fourth-quarter and full-year 2024 Rezdiffra net sales of $103.3 million and $180.1 million, respectivelyAs of year-end 2024, more than 11,800 patients on Rezdiffra Reports cash, cash equivalents ...
In the pivotal Phase 3 MAESTRO-NASH biopsy trial, Rezdiffra achieved both fibrosis improvement and NASH resolution primary endpoints, and 80% of patients treated with Rezdiffra 100 mg experienced ...
Rezdiffra shouldn't be taken by patients with a more advanced form of liver disease called decompensated cirrhosis, the FDA said, and the drug may interact with cholesterol-lowering statins, so ...
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