Obeticholic Acid Under Review for Pre-Cirrhotic Liver Fibrosis Due to NASH
The NDA is supported by two 2 positive interim analyses from the phase 3 REGENERATE trial that included patients with biopsy-proven stage 2 or 3 liver fibrosis due to NASH.
Diagnosis & Disease Information
FDA Approves Citrate-Free, High Concentration of Biosimilar Hadlima
The approval was based on data from a phase 1 study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of Hadlima 100mg/mL to 50mg/mL.
Ibsrela Now Available for Irritable Bowel Syndrome With Constipation
The approval was based on two phase 3 trials which evaluated Ibsrela in over 1200 adults with IBS-C.
Orally Active Amino Acid Mixture Fast Tracked for NASH With Liver Fibrosis
The Company is currently investigating AXA1125 in patients with noncirrhotic NASH with fibrosis in the phase 2b EMMPACT trial.
Benralizumab Gets Orphan Drug, Fast Track Designations for 2 Rare GI Diseases
These rare, chronic relapsing conditions are primarily associated with eosinophilic tissue inflammation.
Oral Prodrug of Testosterone Fast Tracked for Nonalcoholic Steatohepatitis
LPCN 1144 treatment was associated with a statistically significant reduction in liver fat compared with placebo.
Pharmacotherapies for Liver Fibrosis, NASH Resolution Ranked
Although NASH is a common cause of chronic liver disease, there is limited evidence surrounding its management.
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