The Food and Drug Administration has cleared diabetes-management firm DexCom's new continuous glucose monitoring (CGM) system ...

The U.S. Food and Drug Administration has approved a prefilled syringe version of Netherlands-based Argenx SE's blockbuster ...

But now the FDA has rubber-stamped the approval of Luxturna, the first ever gene therapy it has backed, all the attention is now on Spark, and what price it plans to charge for the therapy.