A post by @FirstSquawk on X.
FDA Maintains That Zolgensma and Itvisma Benefits Exceed Potential Risks Within Approved Uses
@FirstSquawk on X
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The FDA has reaffirmed that the benefits of Zolgensma and Itvisma outweigh their potential risks when used within their approved indications, maintaining its existing safety position on the two Novartis gene therapies. The decision removes a near-term regulatory overhang for the treatments, which target spinal muscular atrophy and are part of the company's advanced therapy portfolio. No label changes or new restrictions were announced alongside the review outcome. Investors will watch for any updated prescribing information, post-marketing safety data and future label expansions that could affect the therapies' commercial trajectory.
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Named in this story
FDA, Zolgensma, Itvisma