EU Decision Time On Broader Indication For AbbVie’s Skyrizi
Verdict Also Due On Expanding Olumiant’s Use As COVID-19 Treatment
The European Medicines Agency is meeting this week to consider applications to broaden the use of approved drugs to include new indications in the EU.
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A safety-related FDA revision of Rinvoq’s label in rheumatoid arthritis is a perceived threat to the JAK inhibitor’s growth, but it and fellow immunology asset Skyrizi produced another strong sales quarter.
EU reviewers have recommended marketing approval for two new medicines, but have turned down another product.
The European Medicines Agency wants to make it clearer for drug sponsors what more they can do to address the presence of cancer-causing impurities in active substances, and how to deal with the issue in their regulatory submissions.