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No More NASHing Of Teeth: Madrigal’s Resmetirom Approval Ends Years Of Industry Frustration

 
• By Joseph Haas and Mary Jo Laffler

US FDA clears first MASH (formerly NASH) therapy, nearly four years after one had been initially anticipated. With the accelerated approval path established, Madrigal gets the opportunity to create a marketplace with Rezdiffra (resmetirom), and candidates in the pipeline get a clear target.

Liver disease

With US Food and Drug Administration approval of Rezdiffra (resmetirom) for metabolic-associated steatohepatitis (MASH) with fibrosis, Madrigal Pharmaceuticals, Inc. now faces the challenge of developing the market for MASH, while it awaits competitors who will claim to offer efficacy, safety and/or tolerability advantages.

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Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 
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EMA To Consider Approvals For Eight Orphans, Including Vertex’s CF Drug Alyftrek

 
• By Francesca Bruce

The European Medicines Agency is this week expected issue opinions on whether the European Commission should grant EU marketing authorization for 19 new products.

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US CDC ACIP Puts GSK’s Penmenvy Even With Pfizer, Prepares For Infant MedQuadFi, Lyme Vaccines

 
• By Bridget Silverman

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