Primary Biliary Cholangitis
Mar 27, 2026
GSK’s LYNAVOY Enters PBC Treatment Space, Targeting High-Burden Pruritus Segment
Summary LYNAVOY is an oral IBAT inhibitor approved to treat cholestatic pruritus in adults with PBC, making it the first medicine in the US specifically cleared for this indication. Up to 89% of people with PBC experience cholestatic pruritus, an internal, often unbearable itch that can disrupt sleep, aggrav...
Read More...
Mar 24, 2026
Sanofi’s Venglustat Gains US Breakthrough Therapy Nod, Boosting Hope for Type 3 Gaucher Disease; Rhythm Pharmaceuticals Expands IMCIVREE Label with FDA Approval in Hypothalamic Obesity; FDA Approves LYNAVOY for Cholestatic Pruritus in PBC Patients; FDA Greenlights J&J/Protagonist’s ICOTYDE, Redefining First-Line Systemic Therapy for Plaque Psoriasis; Novartis Strengthens its Breast Cancer Portfolio Through Acquisition of a Pan-mutant PI3Kα Inhibitor
Sanofi Wins US Breakthrough Therapy Tag for Venglustat in Type 3 Gaucher Disease The US Food and Drug Administration (FDA) has awarded Breakthrough Therapy designation to venglustat, an investigational oral glucosylceramide synthase inhibitor (GCSi), for treating neurological symptoms associated with type 3 Gauc...
Read More...
Jun 03, 2025
Beam’s BEAM-302 Earns FDA Orphan Drug Tag for AATD; Incannex’s IHL-42X Moves to Phase III After FDA Protocol OK; Kura and Kyowa Kirin’s Ziftomenib Gets FDA Priority Review in NPM1-Mutant AML; GSK’s Linerixibat NDA Accepted by FDA for PBC-Linked Pruritus; Ascendis’ TransCon CNP Granted FDA Priority Review for Achondroplasia
Beam Therapeutics Secures FDA Orphan Drug Designation for BEAM-302 in AATD Beam Therapeutics Inc. announced that the FDA has granted Orphan Drug Designation to its investigational therapy, BEAM-302, for the treatment of alpha-1 antitrypsin deficiency (AATD). BEAM-302 is a liver-targeting lipid nanoparticle (LNP)...
Read More...
Aug 20, 2024
Gilead’s Livdelzi FDA Approval for Primary Biliary Cholangitis; Incyte and Syndax’s Niktimvo Approved for Graft-Versus-Host Disease; FDA Lifts Hold on BioNTech and MediLink’s ADC Cancer Trial; FDA Approves IMFINZI for Resectable Lung Cancer; Yutrepia Receives Tentative Approval for PAH and PH-ILD
Gilead’s Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by FDA Gilead Sciences, Inc. has received accelerated approval from the FDA for Livdelzi® (seladelpar) in the treatment of primary biliary cholangitis (PBC). Livdelzi can be used in combination with ursodeoxycholic acid (...
Read More...
Jun 11, 2024
Moderna’s Phase III Trials for Dual Influenza and COVID-19 Vaccine; Almirall’s Klisyri FDA Approval; Lilly’s Tirzepatide MASH Trial; Cycle Pharmaceuticals Acquisition of Vanda Pharmaceuticals; Ipsen’s Iqirvo FDA Approval
Moderna Reports Successful Phase III Trials for Dual Influenza and COVID-19 Vaccine Moderna, Inc. has reported that its Phase III trial for mRNA-1083, an experimental combination vaccine targeting both influenza and COVID-19, achieved its main objectives by generating a stronger immune response than the approved...
Read More...
Feb 13, 2024
GSK Receives FDA Fast Track Designation for Bepirovirsen; Gilead to Acquire CymaBay Therapeutics; CSL Announces Top-line Results from the Phase III AEGIS-II Trial; Ruxoprubart Scores FDA Orphan Drug Designation for PNH Treatment; CymaBay Announces FDA Acceptance of NDA and Priority Review for Seladelpar; Biogen Received European Commission Approval for SKYCLARYS
GSK Receives FDA Fast Track Designation for Bepirovirsen in Chronic Hepatitis B GSK plc has revealed that the US Food and Drug Administration (FDA) has awarded Fast Track status to bepirovirsen, an experimental antisense oligonucleotide (ASO) designed to treat chronic hepatitis B (CHB). Fast Track designation ai...
Read More...
Dec 12, 2023
Merck and Moderna Initiate Study to Evaluate V940; FDA Approves Vertex and CRISPR Therapeutics’ CASGEVY for SCD; Novartis Updated on its Investigational Iptacopan Phase III Study; FDA Grants Priority Review for New Drug Application for Elafibranor; FDA Approves bluebird bio’s LYFGENIA for Patients SCD; FDA Fast Track Designation for DMD Gene Therapy
Merck and Moderna Initiate INTerpath-002, a Phase III Study Evaluating V940 in Combination with KEYTRUDA for Adjuvant Treatment of Patients with Certain Types of Resected NSCLC Merck (also known as MSD outside the United States and Canada) and Moderna, Inc. have commenced the INTerpath-002 trial—a crucial Phase ...
Read More...
Feb 13, 2023
PPAR and NOX Agonist: Savior of Underserved Primary Biliary Cholangitis Patients
Primary biliary cholangitis (PBC), earlier known as primary biliary cirrhosis, is an autoimmune disorder that leads to the gradual destruction of intrahepatic bile ducts resulting in periportal inflammation cholestasis. Prolonged hepatic cholestasis subsequently leads to cirrhosis and portal hypertension. As per...
Read More...
Jun 30, 2020
FDA’s No to Intercept’s NASH Drug; Roche’s Phesgo gets approval; Gilead’s Remdesivir pricing
Intercept Pharmaceuticals receives a clear rejection from the FDA for its NASH drug, Obeticholic acid (OCA) Intercept Pharmaceuticals announced the issuance of a Complete Response Letter (CRL) by the FDA regarding the New Drug Application (NDA) for Obeticholic acid (OCA) for the treatment of fibrosis due to ...
Read More...
-Agonist.png "Toll-like Receptors Agonist")
