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Latest From BioProjet SCR
When Breakthrough Falls Short: US FDA Complete Response Letters Rising Among BTD Applications For Approval
More than half of the complete response letters issued for applications holding breakthrough status have been issued since 2020, reflecting difficult – and often rancorous – efficacy debates.
The European Medicines Agency today revealed the names of the latest new products it believes should be approved for use across the EU.
Several companies may appear this week before the European Medicines Agency’s human medicines committee, the CHMP, to answer questions about their initial marketing authorization applications or indication extension requests.
Myovant, Bayer and Rhythm Pharmaceuticals are among the companies that could soon learn whether the European Medicines Agency thinks their drugs are fit for approval.
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