Complete Response Letter

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Biotech

FDA rejects Biohaven approval request, triggering cost cutting

Biohaven responded to the rejection of its neurological disorder therapy by reprioritizing its pipeline to shrink its annual R&D spend by 60%.
Nick Paul Taylor Nov 5, 2025 4:02am
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Unpacking the FDA transparency push on CRLs

Oct 17, 2025 9:41am
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FDA snubs Fortress' Zydus-partnered Menkes disease candidate

Oct 1, 2025 12:00pm
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Capricor responds to cell therapy snub, disputes FDA’s concerns

Sep 9, 2025 11:44am
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FDA rejects another ultrarare disease prospect

Sep 8, 2025 10:59am
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'Several concerning observations': FDA sheds light on rejections

Sep 5, 2025 10:45am