The sNDA was submitted to support full approval of OCA for this indication based on data from the COBALT trial, as well as real-world evidence.

Primary biliary cholangitis (PBC) may be rare, but its impact on women can be profound, leaving too many undiagnosed for ...

The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In ...

Ipsen has been given accelerated approval by the FDA for Iqirvo, which becomes the first dual PPAR alpha/delta agonist for rare cholestatic liver disease primary biliary cholangitis (PBC).

New research from ACG 2024 reveals that primary sclerosing cholangitis raises colorectal cancer risk even in patients without ...

Abstract #5038: Volixibat for Cholestatic Pruritus in Primary Biliary Cholangitis: An Adaptive, Randomized, Placebo-controlled Phase 2b Trial (VANTAGE): Interim Results **Late-breaker poster ...

the Company's lead clinical-stage candidate for moderate-to-severe pruritus in primary biliary cholangitis (PBC). The EMA interactions specifically focused on both the Phase 2 and Phase 3 clinical ...

Ipsen to present new data on elafibranor at The Liver Meeting® 2024Launch of Iqirvo® (elafibranor)1 on track with ...

Primary biliary cirrhosis (PBC ... and primary sclerosing cholangitis (PSC). The most frequent ANA patterns in PBC sera are the 'speckled' (Figure 1), the multiple nuclear dots (MND; Figure ...

TH104, the Company's lead candidate for moderate-to-severe pruritus in chronic liver disease, showed no opioid withdrawal ...

Comparator companies ADVANZ Pharma (Ursodeoxycholic acid, Obeticholic acid) (confidentiality agreement signed, participating) Dr. Falk Pharma UK Ltd (Ursodeoxycholic acid) (confidentiality agreement ...

BRIDGEWATER, NJ / ACCESSWIRE / / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation ...