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Oncopeptides Rescinds Pepaxto Voluntary Withdrawal, Which Could Set Up Battle With US FDA

 
• By Derrick Gingery

After more review of clinical trial data, the myeloma drug’s sponsor wants to talk to the FDA again, but Oncopeptides execs said they cannot disclose the scientific details that led to the decision.

U-turn sign
An Oncopeptides executive said more information on the decision to rescind the withdrawal is expected in the coming months. • Source: Alamy

In another extraordinary move in the short life of the cancer drug Pepaxto, Oncopeptides AB rescinded its voluntary withdrawal of the product’s accelerated approval, and company officials say are barred from disclosing the scientific reasoning for the decision.

Oncopeptides will not resume US marketing of Pepaxto (melphalan flufenamide), a multiple myeloma treatment

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Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
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UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
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UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
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US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
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