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Mesoblast

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FDA Clears Investigational New Drug Application For Mesoblast To Use Remestemcel-L In Severe COVID-19

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Lead Product(s): Remestemcel-L

Therapeutic Area: Infections and Infectious Diseases

Highest Development Status: IND Enabling Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 06, 2020

Details:

FDA clearance provides a pathway in the United States for use of remestemcel-L in patients with COVID-19 ARDS, under both expanded access compassionate use and in planned randomized controlled trial.