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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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.
The EU could become the first market in which eli-cel is approved if the gene therapy for cerebral adrenoleukodystrophy this week passes muster with the European Medicines Agency.