New EU Filings
A regularly updated list of new marketing authorization applications at the EMA
Y-mAbs Therapeutics' omburtamab and Oncopeptides' melflufen are among 13 potential new treatments that have been submitted for pan-EU approval.
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Janssen/Legend Biotech's ciltacabtagene autoleucel and Ipsen's palovarotene are among the latest new medicines that have been submitted for pan-EU approval.
The European Medicines Agency has added 13 new drugs to its list of products that are under review for potential pan-EU marketing approval.
NICE’s decision today affirming the cost effectiveness of Astellas Pharma’s Xtandi for hormone-sensitive metastatic prostate cancer contrasts with the health technology assessment body’s guidance last month for Janssen’s Erleada.