Gastroschisis, a congenital abdominal wall defect, has transformed from a uniformly fatal condition to one with a 95% survival rate through surgical advancements over the past six decades.
FDA is poised to pull Ocaliva as adcomm documents question post-approval study results
The FDA appeared ready to pull its accelerated approval of Alfasigma and Intercept Pharmaceuticals’ rare liver disease drug Ocaliva, bluntly laying out its rationale in