The FDA has approved a new treatment for Fabry disease, a decision that represents the end of a winding, more than decade-long saga for the drug’s developer, Amicus Therapeutics. Its long journey also highlights how drug approval in the U.S. has changed just in the last two years, thanks to new FDA leadership and recent legislation that has put patient voices front and center.
The agency has approved migalastat (Galafold) for adult Fabry patients with a genetic variation responsible for to up to 50 percent of cases. Amicus (NASDAQ: FOLD) CEO John Crowley said the company will price the drug,… Read more »
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