Complete Response Letter

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Biotech

FDA shares CRL for Sanofi MS drug mere weeks after rebuff

Less than two weeks after rejecting Sanofi’s investigational MS drug, the FDA has shared the CRL, citing both efficacy and safety concerns.

Gabrielle Masson Jan 6, 2026 4:30am

Stop sign

FDA rejects Sanofi MS drug, Corcept Cushing's syndrome therapy

Jan 2, 2026 7:10am

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FDA rejects Biohaven approval request, triggering cost cutting

Nov 5, 2025 4:02am

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Unpacking the FDA transparency push on CRLs

Oct 17, 2025 9:41am

end of the road road block shut down closed blocked

FDA snubs Fortress' Zydus-partnered Menkes disease candidate

Oct 1, 2025 12:00pm

Manila folder with CONFIDENTIAL printed on it in red

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

Sep 9, 2025 11:44am