EMA Gives Oncopeptides’ Multiple Myeloma Drug The Thumbs Up; Keeps US FDA In Loop

Company’s Request For EU Conditional Approval Flipped To Full Marketing Authorization

With Pepaxti now on track for pan-EU marketing approval to treat patients with triple class refractory multiple myeloma, Oncopeptides is in talks with the Food and Drug Administration to achieve a clear path forward for the drug in the US where it has experienced difficulties despite being granted an accelerated approval. 

Woman writes in a notebook her observations on work, thoughts and ideas for improving business strategies.
FDA Was A Silent Observer At Most EMA Meetings For Evaluating Melphalan Flufenamide • Source: Shutterstock

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