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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A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval.
The European Medicines Agency today announced the new medicines it believes should be approved for use across the EU.
After Pfizer saw increased risks in a surveillance study of Xeljanz, three other products have also seen their user fee dates pushed back; if FDA were to convene an expert panel, it could lead to more consistent labeling across the class, as requested in a recent citizen petition.