The FDA is reviewing Zolgensma after 9 tumor cases, with 2 showing evidence of possible DNA integration. Novartis already flags a theoretical tumor risk, but the reported cases and review of possible further action make the news unfavorable.
The review puts attention on whether Zolgensma’s safety information and long-term checks are enough. Novartis already warns of a theoretical tumor risk, but the reported cases and possible DNA integration leave a serious safety concern.
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