Complete Response Letter

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Biotech

FDA snubs Fortress' Zydus-partnered Menkes disease candidate

Sentynl and Cyprium were angling the drug candidate to be the first approved treatment for a rare, often fatal pediatric disease.

Zoey Becker 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

FDA

FDA plans real-time release of drug rejection letters

Sep 4, 2025 1:45pm

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FDA flags review of Telix's radiodiagnostic for kidney cancer

Aug 28, 2025 11:20am