A prospective study suggests that the risk of liver fibrosis with methotrexate treatment has been overestimated. The findings suggest the need to reconsider the intensive strategies and the ...
Recent draft guidance highlights the challenges that industry and regulators face to predict rare drug-induced liver injury. At the end of August 2008, the consultation period ended for comments ...
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 ...
†Data from lapatanib-treated patients with metastatic breast cancer [43,93]. ‡Data from pazopanib-treated patients with renal cell carcinoma [31]. §This is a definition of a possible Hy's law ...