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The EC Approves Servier’s Voranigo (vorasidenib) for Grade 2 IDH-Mutant Glioma in the EU 

Shots: The EC has approved Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery, but do not currently require radiotherapy or CT across EEA states  Approval was based on the global pivotal P-III (INDIGO) trial, which demonstrated that vorasidenib significantly improved PFS and TTNI vs…

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BridgeBio

BridgeBio Pharma’s Attruby (Acoramidis) Secures the US FDA’s Approval to Treat ATTR-CM 

Shots:   The US FDA has approved Attruby (oral stabilizer of Transthyretin) to reduce cardiovascular death & associated hospitalization in ATTR-CM patients. The MAA is also under review in the EU, with decision anticipated in 2025 Approval was based on P-III (ATTRibute-CM) study of Attruby vs PBO in ATTR-CM patients (n=632). It achieved its 1EP, showing…

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