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Complete Response for regulatory review of Ultomiris in the treatment of adult patients with neuromyelitis optica spectrum disorder – AstraZeneca

Written by | 15 Sep 2023

The FDA has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz) for the treatment of adult… read more.

New analysis of Uplizna for neuromyelitis optica spectrum disorder is published in Neurology Neuroimmunology & Neuroinflammation – Horizon Therapeutics

Written by | 11 May 2021

Horizon Therapeutics plc announced the publication of a new analysis of the pivotal Phase II/III N-MOmentum trial for Uplizna (inebilizumab-cdon), assessing the potential for reduced risk of worsening… read more.

CHMP recommends approval of Enspryng for neuromyelitis optica spectrum disorder – Roche

Written by | 2 May 2021

Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Enspryng (satralizumab) as the first subcutaneous treatment option… read more.

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