Madrigal Pharmaceuticals’ Rezdiffra (Resmetirom) Receives the EC’s Conditional Approval for MASH with Liver Fibrosis

Shots:The EC has granted conditional approval to Rezdiffra to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with mod. to adv. liver fibrosis in 30 EEA states; launch is planned throughout EU starting with Germany in Q4’25Approval was based on P-III (MAESTRO-NASH) trial assessing Rezdiffra (100 & 80mg, PO, QD) vs PBO in MASH pts, which…

ByRidhi RastogiAugust 20, 2025

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Novo Nordisk Reports the US FDA’s Approval of Wegovy for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Shots:The US FDA has approved a label extension for Wegovy to treat noncirrhotic MASH in adults with mod. to adv. liver fibrosis (F2 to F3 fibrosis) in combination with a reduced calorie diet & increased physical activity; Application submitted to EMA & PMDA in Feb & May 2025, respectivelyApproval was based on Part…

ByRidhi RastogiAugust 18, 2025

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Madrigal Pharmaceuticals’ Rezdiffra Receives the CHMP’s Positive Opinion for MASH with Liver Fibrosis

Shots:The CHMP has recommended Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic MASH with mod. to advanced liver fibrosis; the EC’s decision is expected by Aug 2025Opinion was based on P-III (MAESTRO-NASH) trial assessing Rezdiffra (100 & 80mg, PO, QD) vs PBO in MASH pts, which met its 1EPs of fibrosis improvement…

ByRidhi RastogiJune 23, 2025

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GSK to Acquire Efimosfermin Alfa from Boston Pharmaceuticals for ~$2B, Strengthening its Hepatology Pipeline

Shots:GSK to acquire Boston’s lead asset, efimosfermin alfa, a P-III candidate for steatotic liver disease (SLD)As per the deal, GSK will acquire BP Asset IX (Boston’s subsidiary) for ~$2B to access efimosfermin, incl. $1.2B upfront & $800M in milestones, plus GSK will also be responsible for royalties & milestone payments owed to Novartis…

ByRidhi RastogiMay 14, 2025

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Roche Launches Elecsys PRO-C3 Test for Liver Fibrosis Severity Assessment

Shots:Roche has launched its Elecsys PRO-C3 test, developed with Nordic Bioscience to evaluate the severity of liver fibrosis in pts showing signs of metabolic dysfunction–associated steatotic liver disease Elecsys PRO-C3 test requires a single assay & in combination with ADAPT formula (incl. PRO-C3 levels, platelet count, age, & diabetes status) provides clear assessment of…

ByRidhi RastogiMay 6, 2025

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Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) Receives the US FDA’s Approval to Treat NASH with Liver Fibrosis

Shots: The US FDA has granted accelerated approval to Rezdiffra for treating noncirrhotic NASH with moderate to advanced liver fibrosis (F2 to F3) supported by the P-III (MAESTRO-NASH) study assessing its safety & efficacy at 100mg & 80mg dosing vs PBO in NASH patients (n=1,759) The results after 52wks. showed improved NASH resolution (incl. a…

ByDipanshu DixitMarch 14, 2024

Madrigal Pharmaceuticals’ Rezdiffra (Resmetirom) Receives the EC’s Conditional Approval for MASH with Liver Fibrosis

Novo Nordisk Reports the US FDA’s Approval of Wegovy for Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Madrigal Pharmaceuticals’ Rezdiffra Receives the CHMP’s Positive Opinion for MASH with Liver Fibrosis

GSK to Acquire Efimosfermin Alfa from Boston Pharmaceuticals for ~$2B, Strengthening its Hepatology Pipeline

Roche Launches Elecsys PRO-C3 Test for Liver Fibrosis Severity Assessment

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) Receives the US FDA’s Approval to Treat NASH with Liver Fibrosis

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