Long Regulatory Saga for Intercept Pharma Liver Drug Ends a Decade After Speedy FDA Approval

Health Sector Headlines: From Regulatory Moves to Strikes

Health Sector Headlines: From Regulatory Moves to Strikes In a series of significant developments Thursday, Intercept Pharmaceuticals announced it is withdrawing its liver disease drug, Ocaliva, from the U.S. market, following a request by the Food and Drug Administration. This decision emerges as another challenging moment for the company after the FDA declined full approval for the drug, citing cases of liver injury among patients.Notably, Chi…

Long Regulatory Saga for Intercept Pharma Liver Drug Ends a Decade After Speedy FDA Approval

Intercept Pharmaceuticals is voluntarily withdrawing from the market Ocaliva, a drug for the rare liver disease primary biliary cholangitis. While Ocaliva became an important new treatment option when it won accelerated FDA approval in 2016, PBC patients now have new FDA-approved medicines from Ipsen and Gilead Sciences that don’t pose the same safety risks. The post Long Regulatory Saga for Intercept Pharma Liver Drug Ends a Decade After Speedy…

Intercept pulls Ocaliva off the market in the US

Alfasigma's $800m buyout of Intercept is starting to look like a poor bet as its only product, Ocaliva, is pulled from the market

Intercept Announces Voluntary Withdrawal of OCALIVA® for Primary Biliary Cholangitis (PBC) from the US Market; US Clinical Trials Involving Obeticholic Acid Placed on Clinical Hold

MORRISTOWN, N.J., Sept. 11, 2025 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a wholly owned biopharmaceutical subsidiary of Alfasigma S.p.A., today announced its decision...

Intercept Withdraws Ocaliva from Market After FDA Raises Safety Concerns

Ocaliva, approved for primary biliary cholangitis, faced FDA warnings and restrictions after postmarket data showed higher risks of liver transplant and death among treated patients.

Ocaliva for PBC Withdrawn From US Market

Intercept Pharmaceuticals has voluntarily pulled Ocaliva (obeticholic acid) from the US market following a request from the FDA. The agency also placed a clinical hold on trials involving the drug. Medscape Medical News Source link : https://www.medscape.com/viewarticle/ocaliva-primary-biliary-cholangitis-withdrawn-us-market-2025a1000o4y?src=rss Author : Publish date : 2025-09-11 18:59:00 Copyright for syndicated content belongs to the linked So…