CDRH fees doubled repeatedly. Is regulatory expansion justified? One observer says no. Breakthrough devices and TAP programs ...

A monthly snapshot of FDA activity involving therapies for the prevention and treatment of neurologic diseases.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...

A major amendment has prompted the FDA to extend its review of subcutaneous lecanemab as a starting dose for early Alzheimer disease.

U.S. Food and Drug Administration (FDA) review of oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission ...