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Advisory committee meetings on FDA’s September docket
Up for discussion are a new antibiotic, Ocaliva’s conversion to full approval, and whether to require PD-L1 as biomarker in certain solid tumors
September 6, 2024 11:01 PM UTC
FDA will hold two advisory committee meetings this month to discuss specific products under review, and another with broader implications related to defining PD-L1 expression levels required for treating certain solid tumors with checkpoint inhibitors.
FDA’s Oncology Drugs will meet Sept. 26 to discuss whether use of PD-1 inhibitors that are approved or under review to treat gastric, gastro-esophageal junction (GEJ) and esophageal cancers should be restricted to PD-L1-expressing tumors...
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