New EU Filings
A Regularly Updated List Of New Marketing Authorization Applications At The EMA
Janssen/Legend Biotech's ciltacabtagene autoleucel and Ipsen's palovarotene are among the latest new medicines that have been submitted for pan-EU approval.
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Oncopeptides AB’s melflufen (Pepaxto) has met the primary PFS endpoint in the Phase III OCEAN study, designed to extend its reach into earlier-stage multiple myeloma patients, but overall survival data favors the comparator in patient subgroups, and melflufen in others, leading to regulators pausing clinical trials to review the results.
The European Medicines Agency has added 13 new drugs to its list of products that are under review for potential pan-EU marketing approval.
Orphan drugs and COVID-19 products are among the latest filings under review by the European Medicines Agency for potential pan-EU approval.