The European Medicines Agency is this week deciding whether to recommend pan-EU marketing authorization for a number of new drugs, including odronextamab, Regeneron Pharmaceuticals’ investigational treatment for blood cancers that the US regulator rejected for marketing earlier this year.
US Rejected Drug Odronextamab Among 11 EU Marketing Hopefuls
Regeneron, whose blood cancer treatment odronextamab was recently turned down by the US regulator but not for reasons relating to efficacy or safety, could soon learn whether its product will be among the drugs to get the thumbs up from the CHMP, the European Medicines Agency’s human medicines committee.
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