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- Regulators urge risk-based lifecycle approach for AI tools amid election-linked FDA uncertaintyA panel of regulatory experts at the RAPS AI in Regulatory Conference in Barcelona urged professionals using AI tools to adopt a risk-based, life-cycle perspective rather than focusing solely on va…
- Sarepta halts enrollment in confirmatory Phase 3 trial of Elevidys gene therapy for Duchenne muscular dystrophySarepta Therapeutics announced it will no longer enroll additional patients in the Phase 3 confirmatory study of its gene therapy Elevidys for Duchenne muscular dystrophy. The trial was intended t…