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Intercept Pharmaceuticals, Inc.

http://www.interceptpharma.com

Latest From Intercept Pharmaceuticals, Inc.

Intercept Offloads Ex-US Business To Advanz, May Be Doubling Down On NASH In US

Still working to refile its NASH fibrosis NDA 22 months after an FDA complete response letter, Intercept gets $405m up front for its ex-US business, including commercial rights to Ocaliva in PBC.

Deals Business Strategies

Excuses, Excuses: How ‘Delayed’ Confirmatory Trials Are Explained By FDA

US FDA currently reports about two dozen Accelerated Approval having ‘delays’ in the confirmatory trials. COVID is one factor in some – and the agency also appears to be clearing out some of the others.

Post Market Regulation & Studies Review Pathway

Keeping Track: US FDA Approves Carvykti, Vonjo, But Turns Down Lenacapavir, Filsuvez And GC1507

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Drug Approval Standards

Ipsen Seeks Success Outside Big Pharma's Hunting Grounds

David Loew has assembled a strong business development team which secured seven licensing pacts in 2021 and the Ipsen CEO tells Scrip that this year should see more of the same.

Business Strategies Deals
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