The FDA sent a “refuse to file” letter to EMD Serono, an affiliate of Merck KgA, for the NDA for Cladribine Tablets, an oral formulation of Serono’s cladrribine therapy for relapsing multiple sclerosis. “The company will work closely with the FDA to fully understand FDA’s concerns and define a path forward for a successful resubmission of this application at the earliest point in time,” said Elmar Schnee, Merck KGaA’s head of pharmaceuticals. “W...