Yuhan’s Gaucher drug candidate wins FDA orphan status

Yuhan Corp. said Monday its investigational drug YH35995 has received designation as an orphan drug from the US Food and Drug Administration for the treatment of Gaucher disease. The designation is granted to therapies targeting rare diseases with limited treatment options, offering incentives such as tax credits for clinical trials, exemption from FDA review fees and up to seven years of market exclusivity upon approval. Gaucher disease is a rare inherited lysosomal storage disorder caused by e

By The Korea Herald