Complete Response Letter

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FDA snubs Sobi’s gout drug over manufacturing issues

The FDA cited deficiencies at a contract manufacturing facility and is requiring additional data related to manufacturing control strategy.
Angus Liu Jun 29, 2026 11:04am
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F2G, Shionogi prep regulatory push after antifungal passes ph. 3

Jun 18, 2026 12:01am
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Replimune to lay off staff after 'disappointing' second rejection

Apr 10, 2026 1:56pm
Wooden blocks with arrow and error icon Delays and disruptions stop the process critical error concept

FDA rejects Aldeyra eye disease candidate for 3rd time

Mar 17, 2026 11:12am
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FDA reconsidering Capricor’s snubbed DMD cell therapy

Mar 10, 2026 11:14am
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FDA details Regenxbio rare disease rejection

Mar 3, 2026 12:56pm