欧盟最高药物小组建议批准Merck的Keytruda和为婴儿注射新的RSV疫苗,以待欧盟作出最后决定。
The EU's top drug panel recommended approval for Merck's Keytruda and a new RSV shot for infants, pending final EU decision.
欧洲医药署的CHMP建议批准Merck的癌症药物Keytruda,
The European Medicines Agency's CHMP has recommended approval for Merck's cancer drug Keytruda in a subcutaneous form for all adult EU indications and for treating certain adults with resectable head and neck cancer.
该委员会还建议批准Enflonsia, Merck对婴儿的RSV预防,这将是欧洲第一个,也是唯一的RSV选择,对所有婴儿使用单一剂量,不论体重大小。
The committee also recommended approval for Enflonsia, Merck's RSV preventive for infants, which would be the first and only RSV option in Europe using a single dose for all infants regardless of weight.
这两项建议均有待欧洲联盟委员会进行最后审查,预计将在年底前作出决定。
Both recommendations are pending final review by the European Commission, with decisions expected by year-end.