Tag: accelerated approval
From Withdrawal to Reapproval – Lessons From Gemtuzumab ozogamicin and Belantamab...
Two FDA-approved antibody-drug conjugates (ADCs)—gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth) and belantamab mafodotin (Blenrep®; GSK)—were withdrawn from the U.S. market after confirmatory trials failed to verify...
Accelerated Approval for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial...
The U.S. Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv (Padcev™; Astellas Pharma / Seattle Genetics)* for the treatment of adult...
