Aplidin will be re-evaluated by the EMA. The European Commission revokes the decision that initially denied PharmaMar's marketing authorisation for multiple myeloma due to a conflict of interest.

PharmaMar

8 July 2024 - The European Commission has acknowledged that an expert from the Scientific Advisory Group, who was developing a rival product was allowed to participate in the marketing authorisation procedure for Aplidin (plitidepsin).

PharmaMar has received a notification from the European Commission informing the Company of its decision to revoke the refusal to grant marketing authorisation for Aplidin in multiple myeloma.

Read PharmaMar press release 

Michael Wonder

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Michael Wonder

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Cancer , Medicine , Europe , Regulation , Dossier