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EMA has recommended granting a marketing authorisation in the European Union for a new therapy for the treatment of adult patients with amyotrophic lateral sclerosis (ALS), a rare and often fatal disease that causes muscles to become weak and leads to paralysis. Qalsody (tofersen) is indicated for the treatment of adults with ALS, who have a...

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EMA is holding the eight meeting of the Industry Standing Group (ISG). This forum for interaction has been established as part of the EMA's continuous improvement for engagement with industry stakeholders.

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The Clinical Trials Information System (CTIS) was launched on 31 January 2022, starting the clock for the three-year transition period from the Clinical Trials Directive to the Clinical Trials Regulation.

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