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NEWS

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…
September 19, 2025

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NEWS

IDEAYA Biosciences Partners with Servier to Develop and Commercialize Darovasertib for Uveal Melanoma (UM)

Shots:IDEAYA has entered an exclusive licensing agreement granting Servier global regulatory and commercial rights to darovasertib, while retaining all the US rightsIDEAYA & Servier will co-develop darovasertib & share costs, with Servier leading regulatory & commercial efforts worldwide excl. the US, in exchange for $210M upfront, ~$100M on approval, ~$220M in commercial milestones,…
September 2, 2025

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NEWS

Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma 

Shots: The CHMP has recommended to 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; anticipated EC decision in all 30 EEA states The CHMP opinion is based on the global P-III (INDIGO) trial (N=331), which included…
July 24, 2025

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Servier
NEWS

Servier Reports the US FDA’s Approval of Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma 

Shots:    The US FDA has granted approval to Voranigo (QD) tablets for treating patients (age: ≥12yrs.) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery Approval was based on P-III (INDIGO) trial assessing the safety & efficacy of Voranigo vs PBO to treat residual or recurrent grade 2 glioma with IDH1/2 mutation after…
August 6, 2024

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VIEWPOINTS_Susan Pandya_2024
VIEWPOINTS

Servier at SNO 2023: Dr. Susan Pandya Sheds Light on IDH-Mutant Diffuse Glioma Management

Shots: In a stimulating conversation with PharmaShots, Dr. Susan Pandya shares insights from their presentation at SNO 2023 to strengthen Servier’s Neuro-Oncology Profile While highlighting the details of vorasidenib, Susan articulately explains the study design of the P-III Indigo trial evaluating vorasidenib in patients with IDH-mutant diffuse glioma With a fast-track designation and breakthrough therapy…
March 7, 2024

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PharmaShots' Key Highlights of Second Quarter 2022
INSIGHTS+

PharmaShots’ Key Highlights of Second Quarter 2022

The second quarter of 2022 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Meanwhile, AstraZeneca’s Farxiga (dapagliflozin) meet its primary endpoints for heart failure with a preserved ejection fractionStarting with the latest acquisitions, Pfizer acquire Biohaven for ~$11.6B, GSK acquire Affinivax for ~$3.3B. The second quarter of the year…
June 30, 2022

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