In a move that should come as no surprise to many, the US FDA has requested Oncopeptides AB withdraw the NDA for Pepaxto (melphalan flufenamide), but that development is not necessarily the end of the saga for the product.
Oncopeptides Weighing Pepaxto Withdrawal Request
Drama continues for the multiple myeloma treatment as US FDA formally moves to pull accelerated approval. Oncopeptides anticipates making a decision on the request in the first quarter of 2023.
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