Servier is on course to get a return on its $1.8 billion takeover of Agios Pharma's oncology business after getting a key FDA approval for Tibsovo, the main asset in the deal. The US regulator has ...

Tibsovo (ivosidenib) was already on the market when Servier made its play for Agios' assets, having secured US approvals as a treatment for relapsed or refractory IDH1-mutant AML in 2018 and as a ...

The approved ANDA is therapeutically equivalent to the reference listed drug product Tibsovo tablets, 250 mg, of Servier Pharmaceuticals LLC (Servier), it added. The company said Ivosidenib ...