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Argenica Secures EMA Paediatric Waiver, Fast-Tracking ARG-007 Stroke Approval
9:10am on Monday 2nd of February, 2026 AEDT
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Biotechnology
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Argenica Secures EMA Paediatric Waiver, Fast-Tracking ARG-007 Stroke Approval
9:10am on Monday 2nd of February, 2026 AEDT
Key Points
EMA grants full paediatric waiver for ARG-007 in acute ischaemic stroke
Waiver eliminates costly, impractical paediatric clinical trials
Streamlines European regulatory pathway for adult stroke treatment
Reduces development costs and regulatory risks
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