The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency's drug program, the latest in a string of leadership changes at the agency.

Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty ...

A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of ...

FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and ...