Immune-Modifying Nanoparticle Therapy Fast Tracked for Primary Biliary Cholangitis
The treatment is expected to reprogram the immune system to induce tolerance to PDC-E2.
Digestive and Biliary Disorders
Livmarli Approved for Cholestatic Pruritus in Alagille Syndrome
The approval was based on data from the phase 2b ICONIC study, along with 5 years of data from supportive studies.
Long-Acting Octreotide Therapy Gets Orphan Drug Status for Polycystic Liver Disease
CAM2029 is an investigational ready-to-use, long-acting octreotide subcutaneous injection depot.
Bylvay Approved for Progressive Familial Intrahepatic Cholestasis
Bylvay is an oral reversible inhibitor of the ileal bile acid transporter.
Devimistat Granted Orphan Drug Status for Biliary Cancer
Devimistat targets the mitochondrial tricarboxylic acid cycle selectively in cancer cells.
FDA: Ocaliva Should Not Be Used in PBC Patients With Advanced Cirrhosis
The FDA has identified 25 cases of serious liver injury leading to liver decompensation or liver failure associated with Ocaliva in PBC patients with compensated or decompensated cirrhosis.
Maralixibat Gets Priority Review for Cholestatic Pruritus in Alagille Syndrome
Maralixibat is an oral apical sodium dependent bile acid transporter (ASBT) inhibitor.
FDA to Review Odevixibat for Progressive Familial Intrahepatic Cholestasis
Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport inhibitor.
New Drug Product: Givlaari
This slideshow shows drug information for Givlaari. Click here for the complete Givlaari monograph.
New Pancreaze Formulation Approved With Extended Shelf Life
The Food and Drug Administration has approved a new formulation of Pancreaze (pancrelipase; Vivus) Delayed Release Capsules which would allow for an extended shelf life of 36 months.
