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
Idacio, a Citrate-Free Biosimilar to Humira, Gets FDA Approval
The approval for Idacio was based on a review of data that showed similar pharmacokinetics, efficacy, safety, and immunogenicity to the reference adalimumab product.
Lonafarnib-Based Regimens Look Promising for Patients With Chronic HDV Infection
The all-oral and combination treatment arms demonstrated statistically significant composite responses of 10.1% and 19.2%, respectively.
Oxlumo Indication Expanded to Include Patients With Advanced PH1
The approval was based on data from the phase 3 ILLUMINATE-C study that included 21 dialysis-independent and -dependent patients with PH1.
FDA Approves Aponvie for the Prevention of Postoperative Nausea, Vomiting
Aponvie is a proprietary IV injectable emulsion formulation designed to directly deliver aprepitant as a 30-second IV injection.
Sucraid Single-Use Containers Approved for Congenital Sucrase-Isomaltase Deficienc
Sucraid is an oral enzyme replacement therapy of the genetically determined sucrase deficiency.
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.
Natalizumab Biosimilar to Get FDA Review for MS, Crohn Disease Indications
The application is under review for relapsing forms of multiple sclerosis and Crohn disease.
Ervogastat/Clesacostat Fast Tracked for Nonalcoholic Steatohepatitis
Ervogastat is a diacylglycerol O-acyltransferase 2 inhibitor and clesacostat is an acetyl-CoA carboxylase inhibitor.
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.
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