Navigating the complexities of the pharmaceutical industry, from innovator economics to generics, CRDMO, and biosimilars for ...

Intercept Pharmaceuticals has pulled obeticholic acid (Ocaliva) from the U.S. market as a treatment for primary biliary ...

Ocaliva, approved for primary biliary cholangitis, faced FDA warnings and restrictions after postmarket data showed higher ...

Intercept Pharmaceuticals, a wholly-owned biopharmaceutical subsidiary of Italy’s privately-held Alfasigma, has announced its ...

Ocaliva won accelerated approval for primary biliary cholangitis in 2016, which the FDA refused to upgrade to full approval ...

Intercept Pharmaceuticals has voluntarily removed Ocaliva from the United States market for the treatment of primary biliary ...

Intercept Pharmaceuticals has voluntarily pulled Ocaliva (obeticholic acid) from the US market following a request from the ...

Alfasigma's $800 million buyout of Intercept Pharma two years ago is starting to look like a poor bet, as its only approved ...

Intercept Pharmaceuticals withdraws Ocaliva from the U.S. market following FDA concerns over safety and effectiveness for ...

After years of regulatory struggles for Intercept Pharmaceuticals and its liver disease drug Ocaliva (obeticholic acid), the ...

Intercept Pharmaceuticals said on Thursday it is withdrawing its liver disease drug from the U.S. market following a request from the Food and Drug Administration. This comes as another setback for ...

Intercept Pharmaceuticals, Inc., a wholly owned biopharmaceutical subsidiary of Alfasigma S.p.A., today announced its ...