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The FDA has granted breakthrough device designation to EndoStim for its implantable device which serves as a treatment option for patients with refractory gastroesophageal reflux disease, according to a manufacturer release. The EndoStim System is a neurostimulation device which is implanted laparoscopically and designed to provide long-term reflux control via automatically delivered mild
The FDA issued a complete response letter to Gilead indicating it cannot approve the company’s new drug application that seeks approval of bulevirtide for chronic hepatitis D virus infection and compensated liver disease. In its letter, the FDA cited concerns over the manufacture and delivery of bulevirtide, a first-in-class investigational entry-inhibitor; however, no new studies to assess
Abivax announced that the first U.S. patient has been enrolled in its global phase 3 clinical trial of its oral small-molecule inhibitor obefazimod for the treatment of moderate to severe ulcerative colitis. The trial will include two induction studies – ABTECT-1 (ABX464-105) and ABTECT-2 (ABX464-106) – and a subsequent ABTECT maintenance trial (ABX464-107) that will investigate 25
LONDON — Cirrhosis severity, infections and mortality outcomes were worse for patients in low to middle-income countries, due in part to poor access to liver transplant and ICU facilities, according to data presented here. “We have health care disparities as well as differing populations and diseases that cause cirrhosis around the world,” Jasmohan S. Bajaj, MD, associate
LONDON — A low-carbohydrate, high-fat diet significantly improved nonalcoholic fatty liver disease activity score and HbA1c more than a high-carbohydrate, low-fat diet in people with type 2 diabetes mellitus, according to a researcher here.