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Filing Requirements European Medicines Agency (EMA)

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Kashiv BioSciences Reports Positive Topline Results for XOLAIR® Biosimilar Candidate ADL-018

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On June 25, 2025, Kashiv BioSciences announced positive topline results from its confirmatory Phase 3 trial of ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), in patients with chronic spontaneous urticaria.  ...more

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