Intercept's Ocaliva approval in jeopardy after FDA flags concerns in advisory committee briefing doc
For Intercept Pharmaceuticals’ beleaguered liver disease drug Ocaliva, the hits just keep coming. Ahead of an advisory committee meeting slated for Friday, the FDA on Wednesday unleashed damning ...
The FDA turned down an Intercept Pharmaceuticals drug application for the fatty liver disease NASH, a decision that comes nearly three years after the regulator first rejected the molecule. The agency ...
Intercept Pharmaceuticals, a firm whose treatment for a prevalent liver disease once made it the hottest stock in biotech, said Tuesday it would sell the company for less than $1 billion. Alfasigma, ...
While the path for any drug to go from lab research to commercialization takes years, Intercept Pharmaceuticals now stands as another example that a product’s market exit can also be long and winding.
The Food and Drug Administration rejected Intercept Pharmaceuticals’ investigational treatment for NASH on Thursday, derailing what would have been the first approved medicine for a prevalent liver ...
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