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'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 ,

US FDA panel votes against approval of Intercept fatty liver drug, cites safety issues

(Reuters) -A panel of advisers to the U.S. Food and Drug Administration, wary of the safety of Intercept Pharmaceuticals' oral drug for a type of fatty liver disease, on Friday recommended holding off on an accelerated approval of the medicine. | May. 19 ....

United States , Ruby Mehta , Michael Yee , Leroy Leo , James Floyd , Sriparna Roy , American Liver Foundation , Madrigal Pharmaceuticals , Novo Nordisk , University Of Washington , American Liver , Akero Therapeutics , Bill Berkrot ,

US FDA panel votes against approval of Intercept fatty liver drug, cites safety issues

A panel of advisers to the U.S. Food and Drug Administration, wary of the safety of Intercept Pharmaceuticals' oral drug for a type of fatty liver disease, recommended on Friday holding off on an accelerated approval of the medicine. ....

United States , Leroy Leo , Ruby Mehta , Sriparna Roy , James Floyd , Michael Yee , Madrigal Pharmaceuticals , American Liver Foundation , Thomson Reuters Trust Principles , University Of Washington , Novo Nordisk Novob , Drug Administration , Intercept Pharmaceutical , American Liver , Novo Nordisk , Akero Therapeutics , Thomson Reuters Trust ,

Dating Without Alcohol - The New York Times

Credit.Angie Coates
Dec. 29, 2020
Going out for a drink is a standard first date idea for many singles, but different rules apply if you’re sober.
According to a 2014 survey by the dating app Plenty of Fish, 48.9 percent of singles reported consuming two to three drinks on a first date and 36.4 percent have had a drink before a first date. Unsurprisingly, then, alcohol is a topic that often surfaces quicker than other potential deal-breakers, like political beliefs or relationship history.
Alcohol in Your Life
“Some people identify drinking as, ‘We’re going to have fun’ and some people have the idea, ‘I don’t need alcohol to have fun,’” said Markesha Miller, a therapist based in Columbia, S.C. “That’s an important conversation that needs to happen in the getting-to-know-you stage making sure your values align and the way couples spend time together aligns.” ....

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