This Week’s Biopharma News: Wave of Antibody Approvals - Summary - MDSpire
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This Week’s Biopharma News: Wave of Antibody Approvals

FDA expands Tzield, EU clears Dupixent, and Health Canada approves denosumab antibody biosimilars

  • April 28, 2026

  • 5 min

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The FDA has expanded the approval of teplizumab (Tzield) to include children as young as one year with stage 2 type 1 diabetes, enabling earlier intervention to delay progression. This decision, supported by Phase 4 PETITE-T1D data, marks a significant advance in diabetes therapy. Meanwhile, the FDA is shifting away from animal testing in drug development, promoting human-relevant methodologies. Other significant updates include AstraZeneca's positive Phase III results for tozorakimab in COPD, the EU's approval of dupilumab for chronic hives in children, and Health Canada's approval of denosumab biosimilars by Biocon.

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This Week’s Biopharma News: Wave of Antibody Approvals

  • April 28, 2026

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