FDA Advisory Committee Decides Review Date for Mesoblast’s Remestemcel-L

  • Jul 21, 2020 AEST
  • Team Kalkine

Mesoblast Limited (ASX:MSB) said that the Oncologic Drugs Advisory Committee of the US FDA had scheduled a meeting on 13 August 2020 for the review of data supporting MSB’s Biologics License Application for approval of RYONCIL™ (remestemcel-L) for the treatment of SR-aGVHD in children.

Moreover, RYONCIL is under Priority Review by the FDA with an action date of 30 September 2020, under the Prescription Drug User Fee Act.

Post announcement, MSB quoted at A$3.610 up by 7.761% at AEST 12:01 PM.

 


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