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This study is meant to assess the effectiveness of idebenone on visual function measures in patients with Leber's Hereditary Optic...

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for Raxone (idebenone)...

Santhera has expanded and substantiated its previous regulatory dossier with additional clinical data from patients treated with idebenone, new analyses...

Santhera Pharmaceuticals) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has...

Santhera Pharmaceuticals announces that it has completed patient enrollment in the ongoing Phase IV study (LEROS) with Raxone (idebenone) for...

Santhera Pharmaceuticals announces publication of the previously reported SYROS study data in prominent peer-reviewed medical journal Neuromuscular Disorders , demonstrating...

Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber's Hereditary Optic Neuropathy (LHON) (see section 5.1).

Santhera Pharmaceuticals announced oral explanation at the CHMP of the EMA.

Santhera Pharmaceuticals has announced that it has received a negative opinion on its Marketing Authorization Application (MAA) for Raxone (idebenone)...

Santhera Pharmaceuticals announces the European Commission (EC) has granted marketing authorization for Raxone (idebenone) as the first approved medicine available...