The approval was anchored on data from the pivotal DEVOTE study that investigated the efficacy and safety of the High Dose Regimen of SPINRAZA in ...

Epioxa Provides the Ophthalmic Community and Patients with the First and Only FDA-Approved, Incision-Free, Topical Drug Therapy for Keratoconus Epioxa Represents a Novel, Groundbreaking Therapy for ...

First new FDA-approved treatment option in nearly 20 years for families living with this rare lysosomal storage disease; First FDA-approved medicine in emerging new class of bioth ...

The strength and credibility of the FDA relies on maintaining a clear line between evidence-based, scientific rigor and political priority setting.