Ide-Cel & Enhertu Sponsors Keep Fingers Crossed For EMA Fast-Track
Companies are due to learn this week whether the European Medicines Agency will fast-track its review of their soon-to-be-filed EU marketing applications.
You may also be interested in...
Novel antibody-drug conjugate receives approval in Japan for second-line breast cancer, providing another push to Japanese firm’s strategic plan to build up its oncology operations.
EU marketing applications from Vertex and Roche have reverted to standard review timelines at the European Medicines Agency. The outcomes of three fast-track requests that companies have made for their planned filings are still unknown.
The European Medicines Agency has agreed to review pan-EU marketing applications for a number of new medicines.