May 26, 2010 — The US Food and Drug Administration (FDA) announced today that it has revised the label for orlistat (Xenical) to include new safety information about rare cases of severe liver ...

results the drugmaker says support expanding the product’s label to include this prevalent fatty liver disease. MASH is a metabolic disorder in which the buildup of liver fat leads to worsening ...

The Food and Drug Administration has notified Bristol-Myers Squibb Co. that it must include a so-called black-box warning on its label for the ... life-threatening liver failure can occur with ...

(Reuters) - The prescribing label for Biogen Inc's big-selling oral multiple sclerosis drug Tecfidera has been updated to include a warning of potential liver injury that could require ...

cancer and liver diseases, today announced that the last patient treated under an Open Label Extension program of its concluded Phase II study of Namodenoson in the treatment of hepatocellular ...

But a different medication, one frequently used off-label for the condition, could provide greater benefit to patients with alcohol-associated liver disease, a new study suggests. The data ...

The change removes language from the boxed warnings concerning the potential risk of liver injury. In conjunction with the label update, PAH patients taking Letairis are no longer required to ...

FRANKFURT (Reuters) - German drugmaker will add a warning of rare cases of liver damage to the label of prescription-free stomach relief drops Iberogast after Germany's drugs regulator said a ...