AstraZeneca’s Ultomiris hit with CRL in NMOSD due to issues with risk mitigation strategy - Endpoints News
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AstraZeneca’s rare disease asset Ultomiris was presented with a CRL for neuromyelitis optica spectrum disorder (NMOSD), as the FDA seeks tweaks to the monoclonal antibody’s Risk Evaluation and Mitigation Strategy (REMS). The agency asked that checks be enhanc…