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Complete Response Letter
Pharma
Viatris, Mapi's long-acting MS drug rebuffed by FDA
Viatris likely just lost one of its top product debuts for 2024, thanks to an FDA rejection of a new version of a popular multiple sclerosis drug.
Fraiser Kansteiner
Mar 11, 2024 11:11am
FDA says yes to Allecra's antibiotic combo after CRL for another
Feb 27, 2024 11:44am
Venatorx, Melinta's antibiotic rejected over manufacturing issues
Feb 23, 2024 10:55am
FDA rejects Satsuma's migraine spray over manufacturing concerns
Jan 18, 2024 11:18am
FDA rejects Astellas' zolbetuximab for manufacturing issues
Jan 9, 2024 9:08am
FDA issues CRL for Zealand’s hypoglycemia drug
Jan 2, 2024 9:10am