New EU Filings
Fresenius Kabi’s tocilizumab biosimilar candidate is among the latest medicines that have been submitted for review for potential pan-EU approval.
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EU marketing authorization applications for 12 products, including Skycovion, trastuzumab duocarmazine, alpelisib and sparsenta, are now being evaluated by the European Medicines Agency.
The European Medicines Agency has begun reviewing a new batch of EU marketing authorization applications.
Polyhexanide, from SIFI, could become the first approved treatment for acanthamoeba keratitis, while aflibercept could become the first biosimilar version of Eylea in the EU.