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Mirum Pharmaceuticals

Mirum Reports Topline P-III (EXPAND) Trial Data on Livmarli (Maralixibat) in Ultra-Rare Cholestatic Liver Diseases

Shots: The P-III (EXPAND) trial assessed Livmarli (285µg/kg, BID,PO) vs PBO for cholestatic pruritus in pts (≥6mos.; n=52: 6 adults & 46 pediatric) with ultra-rare cholestatic liver diseases, incl. biliary atresia (BA), achieving statistically significance across all 5 EPs In the pediatric population, Livmarli improved pruritus severity (ItchRO(Obs): −1.81 vs −0.83) & increased days with…

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Amber implants

Amber Implants Reports the US FDA’s 510(k) Clearance of VCFix Spinal System for Treating Vertebral Compression Fractures

Shots: The US FDA has granted 510(k) clearance to VCFix Spinal System for thetreatment of vertebral compression fractures The company plans to launch a US pilot program in early 2026, expand physician access later that year, extend the EXPAND trial into the US, & pursue EU label expansion for stand-alone use & one-level fixation integration…

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