29 January 2026 - Celltrion said Thursday that it has received additional approval from Health Canada for its chronic idiopathic urticaria treatment Omlyclo (omalizumab) in 300 mg pre-filled syringe and 300 mg auto-injector formulations.

The newly approved 300 mg pre-filled syringe and auto-injector formulations are high-dose, single-injection options that deliver the full required dose in one administration, reducing the number of injections needed per treatment. As a result, the company said the formulations are expected to ease patient burden, improve administrative efficiency for healthcare providers, and broaden prescribing flexibility.

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