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.
Gastroenterology
HHS Carcinogen Report Updated to Include 8 Substances
The US Department of HHS added 8 new substances to the 15th Report on Carcinogens, bringing the total list to 256 substances.
Yusimry, a Humira Biosimilar Product, Gets FDA Approval
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira.
Maintenance of Clinical Remission Observed With Mirikizumab in UC Trial
LUCENT-2 is a maintenance study evaluating the efficacy and safety of mirikizumab in patients who achieved clinical response in the 12-week LUCENT-1 induction study.
Prescription Digital Therapeutic Cleared for IBS-Associated Abdominal Pain
Regulora is designed to provide seven 30-minute sessions of remote behavioral therapy based on gut-directed hypnotherapy.
Cyclophilin Inhibitor Fast Tracked for Nonalcoholic Steatohepatitis
In preclinical studies, CRV431 has been shown to reduce liver fibrosis and hepatocellular tumor burden.
Study Investigates Rate of Antidrug Antibody Formation to Biologics Used in IBD
Given that immunogenicity to biologics may contribute to IBD treatment failure, the study authors sought to determine the rate of ADA formation to individual biologic agents.
Bulevirtide BLA Submitted for Chronic Hepatitis Delta Virus Infection
The application submission is supported by data from the ongoing phase 3 MYR301 study, along with completed and ongoing phase 2 studies.
FDA Clears System That Allows for Remote Endoscopy Procedures
PillCam SB3 @HOME offers a telehealth option for direct visualization and monitoring of the small intestine.
Benralizumab Gets Orphan Drug, Fast Track Designations for 2 Rare GI Diseases
These rare, chronic relapsing conditions are primarily associated with eosinophilic tissue inflammation.
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