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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC), 2326 October 2023
A BioSpace report noted that a new safety signal emerged from the TRIUMPH program, though details were limited in the topline data release
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This is the third wave of coordinated enforcement in less than a year: approximately 80 warning letters went out in September 2025, 30 more in March 2026, and 25 more this week
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