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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.
Obesity Drug Imcivree Among Eight New Products To Win EMA Nod
The European Medicines Agency today revealed the names of the latest new products it believes should be approved for use across the EU.
Companies Brace For ‘Oral Explanations’ On EU Filings
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.
Yes Or No? Decisions Due On New EU Drug Applications
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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