Primary biliary cholangitis (PBC) may be rare, but its impact on women can be profound, leaving too many undiagnosed for ...

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’s US president Vivek Devaraj said the pharma company still believes in the evidence supporting the liver disease ...

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 ...

The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...

Journalist Annie Lowrey has a rare disease that causes a near-constant itch that doesn't respond to most treatments. She ...

In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...

Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA declined to grant full approval to ...

Comparator companies ADVANZ Pharma (Ursodeoxycholic acid, Obeticholic acid) (confidentiality agreement signed, participating) Dr. Falk Pharma UK Ltd (Ursodeoxycholic acid) (confidentiality agreement ...

There's been another twist to the tale of Advanz Pharma's efforts to keep its primary biliary cholangitis (PBC) therapy Ocaliva on the market in the EU. Earlier this week, the European Commission ...

Primary biliary cirrhosis (PBC ... and primary sclerosing cholangitis (PSC). The most frequent ANA patterns in PBC sera are the 'speckled' (Figure 1), the multiple nuclear dots (MND; Figure ...