FDA approves Teva and Medincell’s bipolar I disorder treatment
The approval is supported by a combination of current clinical data and model-informed drug development techniques.
Approvals
FDA approves Celltrion’s Eydenzelt for eye diseases
FDA approves Regeneron’s Libtayo for high-risk CSCC post-surgery
Health Canada approves Santhera’s Agamree to treat DMD
NMPA approves Eisai and Biogen for Leqembi IV maintenance dosing
Regeneron’s Evkeeza gains FDA approval for young HoFH patients
EC approves Servier’s Voranigo to treat IDH-mutant glioma
Ionis and Sobi’s Tryngolza gains approval in EU for FCS treatment
