Servier
Servier Garners FDA Priority Review for Tibsovo Regulatory Filing in IDH1-Mutant MDS
The agency will review data Servier has submitted from a Phase I trial showing an 83.3 percent objective response rate and issue a decision by February 2024.
Servier Eyes Approval for Vorasidenib After Positive Phase III Results in IDH1/2-Mutant Glioma
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Vorasidenib increased progression-free survival and time to next treatment versus placebo in results from the INDIGO trial, presented at ASCO this week.
Tibsovo added to a standard two-drug treatment regimen extended event-free survival and reduced treatment failure in patients with IDH1-mutant acute myeloid leukemia.
Servier Nets Tibsovo Approvals in EU for IDH1-Mutant Bile Duct Cancer, AML
European regulators approved these indications based on data from the ClarIDHy trial in bile duct cancer and AGILE trial in AML.
In Brief This Week: Ellipses Pharma, Perspective Therapeutics, Exscientia, Deciphera Pharmaceuticals
News items for the week of March 13, 2023.