The FDA has granted a priority review to the biologics license application seeking the approval of zolbetuximab for the first-line treatment of patients with unresectable, locally advanced or metastatic, HER2-negative, gastric or gastroesophageal junction adenocarcinoma whose tumors are Claudin18.2 positive.
Astellas Submits New Drug Application for Zolbetuximab in Japan 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.
/PRNewswire/ Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the submission of a New Drug Application (NDA).