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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EU reviewers have recommended marketing approval for two new medicines, but have turned down another product.
A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval.
Drug regulators from five countries have outlined their joint expectations on the data companies must submit for the approval of next-generation COVID-19 vaccines if they opt for immunobridging studies instead of large-scale efficacy trials.