The Food and Drug Administration (FDA) will not be meeting the Jan. 12, 2024 approval deadline for zolbetuximab to treat certain patients with gastric or gastroesophageal junction adenocarcinoma.
TOKYO, Jan. 8, 2024 /PRNewswire/ Astellas Pharma Inc. today announced the U.S. Food and Drug Administration issued a complete response letter on January 4, 2024, regarding the Biologics License.
The FDA has issued a complete response letter regarding the biologics license application seeking the approval of zolbetuximab for the treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are Claudin18.2 positive
FDA rejects Astellas zolbetuximab for manufacturing issues fiercepharma.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from fiercepharma.com Daily Mail and Mail on Sunday newspapers.
Astellas Provides Update on Zolbetuximab Biologics License Application in U S webwire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from webwire.com Daily Mail and Mail on Sunday newspapers.