JD Supra12h
FDA Advisory Committee outlines informed consent best practices
The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed ...
FiercePharma2d
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 ...
BioSpace13d
Lexicon Loses FDA Adcomm Vote on Insulin Adjunct for Patients With Type 1 Diabetes
While an FDA advisory committee saw signals of efficacy for Lexicon Pharmaceuticals’ sotagliflozin, the panel of external ...
medtechdive14d
Michelle Tarver faces challenges as new CDRH leader. But patient groups, industry are optimistic.
Patient advocates are hoping for change under new director Michelle Tarver, while industry groups look to build on former ...
Business Wire23d
FDA’s Oncologic Drugs Advisory Committee Decision on Checkpoint Inhibitors Substantiates Potential of CEL-SCI’s Multikine® to Address Major Treatment Gap for PD-L1 ...
Advisory committees make non-binding recommendations ... 2024 ODAC meeting evaluated the use of checkpoint inhibitors on patients with various cancers. PD-L1 is the biomarker most often used ...
Managed Healthcare Executive13d
FDA Advisory Committee Votes Down Sotagliflozin in Type 1 Diabetes and CKD
Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently ...