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Australias TGA has approved it as iTRAM for intra-articular knee osteoarthritis

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"This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America's leadership in developing innovative medicines." - Stphane Bancel, chief executive officer of Moderna Moderna stated in its announcement that the RTF letter contradicts prior written guidance from CBER

Jessica Bartlett can be reached at [email protected]