SanBio Co (JP:4592) has released an update.
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SanBio Co., Ltd. has updated stakeholders on the approval process of their AKUUGO suspension for intracranial implantation, emphasizing the submission of additional data and the plan for further analysis and production runs prior to shipping post-approval for partial changes. The approval includes unique conditions regarding quality assessments and the requirement for use in specialized medical settings by experienced physicians, with a commitment to post-marketing evaluation.
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