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FDA Approves Ekterly Amid Industry Turmoil and Triumphs

7/7/2025

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Summary

Story summary

The FDA has greenlit KalVista Pharmaceuticals' Ekterly, a breakthrough for those suffering from hereditary angioedema. Meanwhile, Cogent Biosciences unveiled promising Phase 3 results for bezuclastinib in systemic mastocytosis. However, Jasper Therapeutics is grappling with a potential manufacturing defect in briquilimab, all while the FDA struggles with morale issues stemming from staffing cuts and political turmoil.

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Story summary

The FDA has greenlit KalVista Pharmaceuticals' Ekterly, a breakthrough for those suffering from hereditary angioedema. Meanwhile, Cogent Biosciences unveiled promising Phase 3 results for bezuclastinib in systemic mastocytosis. However, Jasper Therapeutics is grappling with a potential manufacturing defect in briquilimab, all while the FDA struggles with morale issues stemming from staffing cuts and political turmoil.