EU Regulators Reject Merck KGaA's Oral MS Drug Cladribine
This article was originally published in The Pink Sheet Daily
Executive Summary
Surprise rejection hits German drugmaker hard and casts doubt over FDA approval.
You may also be interested in...
Merck KGaA Pins Cladribine Hopes On Ongoing Studies After Complete Response Letter
The oral MS therapy adds the FDA rebuff to a January EU rejection; both regulatory bodies want to get a better fix on the drug's risk/benefit profile.
Merck KGaA Pins Cladribine Hopes On Ongoing Studies After Complete Response Letter
The oral MS therapy adds the FDA rebuff to a January EU rejection; both regulatory bodies want to get a better fix on the drug's risk/benefit profile.
Merck KGaA Pins Cladribine Hopes On Ongoing Studies After "Complete Response" Letter
Merck KGaA is hoping data from already completed and ongoing studies will satisfy FDA's need to better understand the risk-benefit profile for its oral multiple sclerosis therapy cladribine, after the agency issued a "complete response" March 2.