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.
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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.
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.
Decisions are due on several EU marketing applications at the March meeting of the European Medicines Agency’s drug evaluation committee, the CHMP. Also, a number of companies might be asked to address outstanding issues the CHMP has about products they want to market that are near the final stages of review.