US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
Medpage Today on MSN3d
FDA Rejects Full Approval of Liver Disease Drug
The FDA in 2016 granted accelerated approval to the FXR agonist as a second-line treatment for adults with PBC, either in ...
GlobalData on MSN2d
Intercept loses Ocaliva FDA full approval bid in rare liver disease
Intercept’s US president Vivek Devaraj said the pharma company still believes in the evidence supporting the liver disease ...
The American Journal of Managed Care11h
Delandistrogene Moxeparvovec Fails to Meet Primary Endpoint in Phase 3 Study
Put up against placebo in the phase 3 EMBARK trial, delandistrogene moxeparvovec (Elevidys) did not significantly improve ...
FiercePharma3d
FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...
Monthly Prescribing Reference2d
FDA Denies Full Approval of Obeticholic Acid for Primary Biliary Cholangitis
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.
FiercePharma1d
PTC wins FDA approval for first brain-delivered gene therapy Kebilidi
The FDA issued its first stamp of approval for a cell or gene therapy back in 2017 to Novartis' Kymriah. | The gene therapy ...
BioPharma Dive1d
PTC wins US approval of gene therapy for fatal enzyme disorder
Kebilidi is the first approved gene therapy that can be directly administered to the brain. Its OK secures a priority review ...
Becker's Hospital Review2d
FDA rejects full approval of liver disease drug
In a letter issued to Intercept Pharmaceuticals, the FDA stated it could not approve the drug for full use ... the U.S under its current accelerated approval status. Intercept plans to work ...