Still hunting a blockbuster, Merck KGaA scores a win in the FDA approval column — more than 13 years in the making

Thirteen years after it was put on the FDA’s fast track, and 8 years after the agency spurned it in a direct rebuke for an inadequate late-stage development program, Merck KGaA’s multiple sclerosis drug cladribine is finally making its US debut. The agency OK’d the oral drug on Friday for patients who had failed at least 1 drug.