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.
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.
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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