A comprehensive view of Complete Response Letters (CRL) / Disapproval. This page highlights a small sample of our full coverage.
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FDA denies approval for Viatris and Mapi Pharma's monthly multiple sclerosis injection GA Depot; Viatris confirms decision will not impact future revenue or new product range
Published: March 12, 2024 by CE Noticias Financieras
FDA rejects Eli Lilly's eczema treatment lebrikizumab due to issues found during inspection at third-party contract manufacturing organization; FDA has rejected three Lilly drugs this year
Published: October 02, 2023 by FiercePharma
Regeneron suffers set-back for release of new version of high-dose Eylea eye-medicine after FDA rejects approval request due to manufacturing issue; FDA raises no safety or efficiency issues, or demand for new trials
Published: June 28, 2023 by BioPharma Dive

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