Shire Withdraws Replagal BLA Rather Than Conduct Lengthy Trials – Updated
Distributed free of charge to U.S. patients with Genzyme’s Fabrazyme in short supply, Replagal seemed destined for quick approval, but FDA has signalled otherwise.
Distributed free of charge to U.S. patients with Genzyme’s Fabrazyme in short supply, Replagal seemed destined for quick approval, but FDA has signalled otherwise.