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USA | FDA Accepts Wearable-Derived Foot-Drop Measure into ISTAND — Digital Outcomes Advance in Rare-Disease Development

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USA | FDA Accepts Wearable-Derived Foot-Drop Measure into ISTAND — Digital Outcomes Advance in Rare-Disease Development2026-10-18T12:59:39+00:00

USA | Natural-History Evidence Supports FDA Approval of First Gene Therapy for Sanfilippo Syndrome Type A

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USA | Natural-History Evidence Supports FDA Approval of First Gene Therapy for Sanfilippo Syndrome Type A2026-10-18T12:22:51+00:00

JAPAN | PMDA Proposes Review Points for Generative-AI Medical Devices — Real-World Performance and Lifecycle Monitoring Move Into Focus

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JAPAN | PMDA Proposes Review Points for Generative-AI Medical Devices — Real-World Performance and Lifecycle Monitoring Move Into Focus2026-10-18T10:07:38+00:00

JAPAN | Post-Marketing Evidence Supports Paediatric Melatonin Label Revision — Trial Evidence Gap Remains Explicit

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JAPAN | Post-Marketing Evidence Supports Paediatric Melatonin Label Revision — Trial Evidence Gap Remains Explicit2026-10-18T10:03:26+00:00

INDIA | New ADR-PvPI 2.0 App Broadens Digital Safety Reporting Across Medicines, Vaccines and Devices

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INDIA | New ADR-PvPI 2.0 App Broadens Digital Safety Reporting Across Medicines, Vaccines and Devices2026-10-18T09:57:30+00:00
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