Complete Response Letter

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Biotech

FDA denies request to reconsider Stealth's ultrarare disease med

The biotech says it's "evaluating all options" after the FDA directed the biotech to resubmit a new drug application for its rare disease candidate.
Gabrielle Masson Aug 8, 2025 1:58pm
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Replimune's request for melanoma approval rejected by FDA

Jul 22, 2025 8:45am
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Favicon Fierce Pharma

FDA snubs Ultragenyx gene therapy over manufacturing issues

Jul 14, 2025 10:16am
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Favicon Fierce Pharma

FDA's response letter salvo sheds light on drug refusal process

Jul 11, 2025 10:15am
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FDA rejects Capricor’s DMD cell therapy, asks for more data

Jul 11, 2025 9:18am
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FDA shares more than 200 CRLs for now-approved drugs

Jul 10, 2025 10:54am