Two years after undergoing a heart transplant, 12-year-old Jabri Fox says she's a changed person, cognizant that life is full ...
The sNDA was submitted to support full approval of OCA for this indication based on data from the COBALT trial, as well as real-world evidence.
The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In ...
A new study finds that eliminating radiation from conditioning regimens in patients with dyskeratosis congenita undergoing ...