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Latest From Oncopeptides AB
Accelerated Approvals: Conversions Still Outweigh Withdrawals, But Takeda’s Exkivity Brings 2023’s Pull Count To Six
US FDA’s Oncologic Drugs Advisory Committee will convene in November for a ‘general discussion about delayed confirmatory trials’ and the ‘continued optimization of the accelerated approval process.’
The European Medicines Agency has recommended new uses for 11 approved medicines, including an antibody drug conjugate for treating advanced non-small cell lung cancer.
Pink Sheet Podcast: What We Learned From The First Medicare Price Negotiation List, Pepaxto Withdrawal Update
Pink Sheet reporters and editors consider lessons and next steps after the first list of drugs subject to Medicare price negotiations was released and discuss Oncopeptides’ Pepaxto facing withdrawal under the US FDA’s new and potentially faster process.
The US FDA is free from the need to reconsider Accelerated Approvals in a formal hearing in front of an advisory committee. But now the agency is now trying that approach to hear an appeal of a rejected application.
- Large Molecule
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