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- FDA staff raise concerns over Replimune's skin cancer drug dataFDA staff have reiterated concerns that Replimune's investigational skin cancer therapy lacks sufficient data for approval. The agency highlighted the single-arm trial, in which patients previousl…
- FDA’s AI push faces uncertainty after key leaders departThe FDA has been pushing artificial intelligence across the agency, unveiling a large-language-model tool called Elsa to help draft and summarize review reports and announcing plans to use agentic…