That helped offset a 5.4% drop for Sarepta Therapeutics, which continued to fall after the Food and Drug Administration said on Friday that it asked the company to voluntarily stop all shipments of ...

Analysts questioned whether the complete response letter Replimune received was evidence of changing approval standards at ...

Sarepta will stop shipping its Duchenne muscular dystrophy gene therapy Elevidys following ongoing discussions with the FDA over safety labeling. The drugmaker said the pause, effective July 22, will ...

Dr. George Tidmarsh, a Stanford pediatrics adjunct professor and former pharmaceutical executive, is FDA Commissioner Marty Makary’s pick to be the nation’s top drug regulator.