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Mesoblast Says FDA Supports Accelerated Approval Pathway for Heart Failure Treatment
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Mesoblast Says FDA Supports Accelerated Approval Pathway for Heart Failure Treatment
Mar 11, 2024 2:31 AM

05:13 AM EDT, 03/11/2024 (MT Newswires) -- Mesoblast (MESO) said Sunday the US Food and Drug Administration supports an accelerated approval for its rexlemestrocel-L cell therapy in end-stage heart failure patients with a left ventricular assist device.

The regulator provided the feedback to the company in a February meeting. The product is being designed for patients with ischemic heart failure with reduced ejection fraction.

The company intends to request a pre-biological license application meeting with the FDA to discuss potential accelerated approvals for the therapy.

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