Complete Response Letter

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Podcast

Unpacking the FDA transparency push on CRLs

This week on “The Top Line,” we unpack how the FDA’s approach to CRL disclosure is evolving—and what the new timing and scope mean for biopharma.
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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
FDA

FDA plans real-time release of drug rejection letters

Sep 4, 2025 1:45pm