15 August 2023 - Submission supported by comprehensive clinical data package, including updated results that demonstrate durable remissions and an acceptable safety profile.

Servier today announced the US FDA has accepted a supplemental new drug application and granted priority review for Tibsovo (ivosidenib tablets) in the treatment of patients with isocitrate dehydrogenase 1 mutated relapsed or refractory myelodysplastic syndromes.

Read Servier press release