Live Breaking News & Updates on Gastrointestinal Drug Advisory Committee

Stay updated with breaking news from Gastrointestinal drug advisory committee. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.

Lead NASH contender falls short for FDA: Could NAFLD name change shift the status quo?

In the race for a first-to-market therapy for nonalcoholic fatty liver disease and nonalcoholic steatohepatitis, there have been multiple hopeful contenders; however, none have yet crossed the FDA finish line. Last month, the FDA rejected the lead NASH drug contender, obeticholic acid, due to concerns that its risks outweigh its benefits. This action leaves Madrigal Pharmaceuticals’ ....

United States , United Kingdom , Philip Newsome , Monica Stonehill , Bykate Young , Intercept Pharmaceuticals Do , Gastrointestinal Drug Advisory Committee , Nomenclature Steering Committee , University Of Michigan Health , University Of Birmingham , Madrigal Pharmaceuticals , Global Liver Institute , Madrigal Pharmaceutical , Steering Committee , Intercept Pharmaceuticals , Knowledge Transfer , Dental Sciences , Michigan Health ,

Intercept 'disappointed' after FDA setback for top NASH contender; stock drops 16%

Intercept Pharmaceuticals saw a 16% drop in its stock value after an FDA advisory committee declined to approve obeticholic acid in pre-cirrhotic patients with liver fibrosis due to nonalcoholic steatohepatitis.
The vote before the Gastrointestinal Drug Advisory Committee on May 19 was Intercept’s second bid to put its 25 mg obeticholic acid product (Ocaliva) in a lead position as the first ....

Thomas Capozza , Jerry Durso , Ruby Mehta , Intercept Pharmaceuticals , Gastrointestinal Drug Advisory Committee On , Office Of New Drugs , Gastrointestinal Drug Advisory Committee ,

'Unfavorable benefit-risk': FDA panel votes against obeticholic acid approval for NASH

An FDA advisory committee voted against approval for obeticholic acid in pre-cirrhotic patients with liver fibrosis due to nonalcoholic steatohepatitis, citing “concerning” risk/benefit profile. ....

Franka Anania , Benjamin Lebwohl , Thomas Capozza , Sangeeta Sawhney , Ruby Mehta , Intercept Pharmaceuticals , Gastrointestinal Drug Advisory Committee , Office Of New Drugs , Intercept Pharmaceuticals Do , New Drugs ,

Laine Named Digestive Diseases Section Chief

Laine Named Digestive Diseases Section Chief
yale.edu - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from yale.edu Daily Mail and Mail on Sunday newspapers.

United States , Los Angeles , Loren Laine , Paulb Beeson , Michael Nathanson , Gastrointestinal Drug Advisory Committee , Yale School Of Medicine , National Institutes Of Health , Faculty Assembly , Fecal Microbiota Transplantation National Registry Steering Committee , Staff Association , Healthcare Network , National Randomized Proton Pump Inhibitor Program Ra , Department Of Veterans Affairs , University Of Southern California School , Clinical Research , American Gastroenterological Association , Department Of Medicine , Vice Provost For Faculty Development , Internal Medicine , Yale Section , Digestive Diseases , Yale School , Department Chair Gary , Vice Provost , Faculty Development ,