Merck Serono

Stymied in U.S., Merck KGaA wins an approval for cladribine

As Merck KGaA wrestles with FDA regulators over its application for the oral MS drug cladribine, the German pharma company won its first approval for the drug--in Russia. Merck KGaA's cladribine filing was stiff-armed at the FDA last fall when the agency refused to accept it for review. The pharma company refiled in the U.S. in June. But Russia has already offered its approval, and Merck Serono says it expects more markets to follow in short order. "This is an important milestone...
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