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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Applications for the accelerated assessment of planned EU marketing applications for two drugs are being considered by the European Medicines Agency.
The sponsor of an ophthalmic formulation of bevacizumab is set to speak up for its marketing authorization application during a European Medicines Agency oral explanation meeting.
Health technology assessment body NICE has also issued guidances rejecting three products.