Contrasting decisions by the European Medicines Agency and the US Food and Drug Administration relating to Merck & Co. Inc.’s blockbuster immunotherapy product, Keytruda (pembrolizumab), have again illustrated the potential for the two regulators to disagree over whether a new product, indication or dosing schedule should be approved.
At the end of January, the EMA announced that Merck Sharp & Dohme, as Merck is known in Europe, had...
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