Three Cell And Gene Therapies Reach Critical Review Stage In EU
BMS, bluebird bio And PTC Therapeutics Need To Address Reviewers' Outstanding Issues
A number of advanced therapies are likely to be approved in the EU this year.
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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.
The European Medicines Agency today announced the new medicines it believes should be approved for use across the EU.
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.