MedPage Today18 天
FDA Rejects Full Approval of Liver Disease Drug
Opens in a new tab or window The FDA declined to grant full approval to obeticholic acid (Ocaliva) for treating primary ...
pharmaphorum7 年
Intercept's Ocaliva approved in EU for liver disease
The European Commission has approved Intercept’s Ocaliva (obeticholic acid) for the liver disease ... a potent and selective agonist of the farnesoid X receptor (FXR), which is expressed at ...
GlobalData on MSN1 天
Advanz Pharma’s liver disease drug pulled from European market after court hearing
This latest update comes after Advanz secured a suspension of the European Commission’s original revocation in September 2024 ...
GlobalData on MSN1 个月
Intercept’s liver disease drug Ocaliva faces FDA approval delay
Intercept Pharmaceuticals will have to keep waiting for a decision about Ocaliva (obeticholic ... Ocaliva activates the ...
Monthly Prescribing Reference16 天
FDA Denies Full Approval of Obeticholic Acid for Primary Biliary Cholangitis
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.
Intercept Receives Complete Response Letter from FDA Addressing OCALIVA supplemental New ...
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 ...