New EU Approvals
The Pink Sheet’s list of EU centralized approvals of new active substances now includes a new product, Alexion Pharmaceuticals' Ultomiris, for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).
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Three companies are set to learn this week whether the European Medicines Agency will fast track its review of their soon-to-be-filed EU marketing applications.
Janssen and AstraZeneca are among a raft of companies that might this week find out whether the European Medicines Agency will recommend approval of their products for expanded therapeutic indications.
Oral explanation meetings are due to take place this week for drug sponsors who have a final chance to address questions and concerns the European Medicines Agency has about their marketing applications.