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News about "Thomas Nusbickel"
Celltrion Gets FDA Nod for 300mg OMLYCLO, the First Interchangeable Xolair Biosimilar
The US FDA has approved 300 mg/2 mL prefilled syringe formulation of OMLYCLO (omalizumab-igec), expanding dosing options for patients with certain allergic diseases and supporting more personalised treatment. OMLYCLO—the first and only biosimilar interchangeable with XOLAIR (omalizumab)—previously received approval for its 75 mg and 150 mg strengths.
Thomas Nusbickel | 03/12/2025 | By Dineshwori
Prometheus Laboratories Collaborates with Celltrion for Anser Testing
Prometheus is the first specialty lab to validate TDM testing for both intravenous and subcutaneous infliximab, supporting the growing demand for at-home treatment options.
Thomas Nusbickel | 28/08/2025 | By Dineshwori | 107
Celltrion Secures US FDA Approval for Expanded Indication for AVTOZMA
Celltrion has received FDA approval for an expanded indication of AVTOZMA IV (tocilizumab-anoh) to treat cytokine release syndrome (CRS), achieving full indication parity with reference biologic ACTEMRA IV in the US.
Thomas Nusbickel | 07/08/2025 | By Mrinmoy Dey | 109
Celltrion's YUFLYMA Achieves FDA Interchangeable Status
YUFLYMA is an FDA-approved, high-concentration (100mg/mL) and citrate-free formulation of Humira® biosimilar, approved for multiple inflammatory indications.
Thomas Nusbickel | 15/04/2025 | By Abha | 340
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