FDA to decide on full approval for Ocaliva in treating adults with PBC
The U.S. Food and Drug Administration (FDA) agreed to review an application seeking full and formal approval of Ocaliva (obeticholic acid) as a…
Cholangitis
Phase 2 study of LB-P8 for PSC nets FDA clearance
LISCure Biosciences will launch a Phase 2 trial in the United States to evaluate the safety and effectiveness of LB-P8, its live bacterium candidate…
Seladelpar found to reduce disease activity, itch in PBC patients in trial
Daily treatment with seladelpar, CymaBay Therapeutics’ investigational oral candidate for people with primary biliary cholangitis (PBC), was shown to normalize liver biomarkers and…
Patents covering CM-101, potential PSC therapy, given in Brazil, Israel
Chemomab Therapeutics has been awarded patents in Brazil and Israel covering CM-101, the company’s experimental therapy that’s currently being tested in a Phase…
Bexotegrast shows positive signs as PSC treatment in Phase 2 trial
Pliant Therapeutics’ investigational oral treatment bexotegrast safely eases itching and is associated with signs of better liver function and less liver scarring, or fibrosis, in…
FDA to review approval application for seladelpar as PBC treatment
The U.S. Food and Drug Administration (FDA) will review CymaBay Therapeutics’ application for seladelpar, an oral investigational treatment for adults with…
Seladelpar lowers levels of molecule driving itch with PBC: Phase 3 trial
Seladelpar, an experimental oral therapy by CymaBay Therapeutics, significantly lowered blood levels of an itch-associated molecule called interleukin-31 (IL-31) in people with…
Health Canada Approves Ocaliva for Autoimmune Liver Disease Patients
Canadian patients with the autoimmune liver disease primary biliary cholangitis (PBC) saw the first approval of a new drug for their condition in more than…
Genkyotex’s GKT831 Drug Moves to Phase 2 Trial After Winning FDA Investigational New Drug Status
The U.S. Food and Drug Administration (FDA) has granted investigational new drug (IND) status to GKT831, allowing French pharmaceutical company Genkyotex to advance its drug to a Phase…
First Patient Enrolled in Phase 2 Clinical Trial of Elafibranor for Bile Duct Disease
GENFIT has enrolled the first patient in a Phase 2a clinical trial of elafibranor as a treatment for a liver bile duct disease known as primary…
Recent Posts
- Abnormal amino acid profile seen in biliary atresia infants after birth
- Our daughter’s PFIC diagnosis made us rethink drinking at Christmas
- Hepatitis D treatment combo granted new designations in US, EU
- Committee recommends seladelpar approval in EU for treating PBC
- Diet rich in omega-3 fatty acids may lower risk of ICP, scientists say