LB-P8 probiotic on FDA fast track for primary sclerosing cholangitis
The U.S. Food and Drug Administration (FDA) has granted fast track designation to LB-P8, LISCure Biosciences’ experimental live bacterium product that is headed toward…
Cholangitis
Phase 1b/2 trial of golexanolone for PBC behavioral symptoms advances
Golexanolone, Umecrine Cognition’s investigational oral therapy, was generally safe and well tolerated in adults with primary biliary cholangitis (PBC) and clinically significant…
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…
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…
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