Primary biliary cholangitis (PBC) may be rare, but its impact on women can be profound, leaving too many undiagnosed for ...
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.
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Intercept loses Ocaliva FDA full approval bid in rare liver diseaseIntercept’s US president Vivek Devaraj said the pharma company still believes in the evidence supporting the liver disease ...
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 ...
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
BRIDGEWATER, NJ / ACCESSWIRE / / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation ...
Journalist Annie Lowrey has a rare disease that causes a near-constant itch that doesn't respond to most treatments. She ...
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 ...
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...
Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA declined to grant full approval to ...
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).
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