BeiGene’s Brukinsa Among Five Orphan Drugs Awaiting EU Approval Verdict
Sponsors Of Two Other Medicines May Have To Address Last-Minute Issues
Sponsors of several new medicines are set to learn if their products are on track for pan-EU approval. One product on the list is Pfizer/Lilly’s osteoarthritis drug, tanezumab, which recently ran into trouble in the US.
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Gilead Awaits EMA Verdict On Trodelvy As It Whizzes Through EU Review
Sponsors of six new products, including a first-in-class treatment for unresectable locally advanced or metastatic triple-negative breast cancer, will find out this week if their products are on course to be approved for use in the EU. Also, two sponsors might be asked to address last-minute questions about their drugs.
BeiGene’s Brukinsa Among Nine Drugs To Win EU Marketing Thumbs Up
A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval.
EMA Says Yes To Eight New Medicines, Holds Fire On Others
The European Medicines Agency today announced the new medicines it believes should be approved for use across the EU.