Complete Response Letter

Manila folder with CONFIDENTIAL printed on it in red
Biotech

Capricor responds to cell therapy snub, disputes FDA’s concerns

Capricor called the rejection "difficult to understand" because the FDA had originally okayed the company's submission plan.
Darren Incorvaia 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
FDA stop sign

FDA flags review of Telix's radiodiagnostic for kidney cancer

Aug 28, 2025 11:20am
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Krystal discontinues melanoma study after FDA's Replimune rebuff

Aug 21, 2025 10:50am