The FDA is allowing Sarepta to resume shipments of Elevidys (delandistrogene moxeparvovec) to ambulatory patients with Duchenne muscular dystrophy.

The FDA's top vaccine official is stepping down after just 3 months in a role that upset drug companies, patient groups and some political leaders.

Since becoming Vertex's top scientist in 2015, Altshuler has helped the company become an industry powerhouse. He’ll depart ...

While the deaths occurred in patients who had been treated with Agios’ anemia treatment Pyrukynd, the biotech insisted in an ...