FDA's 2026 shift to a single pivotal trial as the default approval standard forces sponsors to rethink Phase 3 design before the next IND meeting.
Merry Life Biomedical starts Phase 2 trial of TML-6, an oral drug targeting autophagy-lysosomal pathways in early Alzheimer's ...
Roche's enicepatide met Phase II endpoints in type 2 diabetes trial, demonstrating dose-dependent reductions in HbA1c and body weight over 48 weeks.
European Commission approves obicetrapib, a CETP inhibitor for hypercholesterolemia, offering oral dosing and 41% LDL-C reduction in Phase 3 trials.
Ivonescimab plus chemotherapy achieved a statistically significant overall survival benefit over durvalumab in biliary tract ...
Risk-based source data verification adoption reaches 96% in clinical trials, reshaping how monitors prioritize verification ...
FDA Part 11 Compliance requires validated systems, audit trails, and electronic signatures linked to individual users. Learn ...
Radial's FDA-cleared Evoke EEG integration across 27 brain medicine clinics tests whether distributed neuroimaging endpoints ...
Phase III Clinical Trials now generate 5.9M data points annually with 11% yearly growth, raising questions about managing ...
A new target trial emulation in Lancet Psychiatry challenges antipsychotic-first strategies in early psychotic mania. Here's ...
Accro Bioscience doses first patient in AC-101 Phase IIb trial for ulcerative colitis, targeting the NOD/RIPK2 pathway with a 12-week clinical remission endpoin ...
Daejin Abidoye, Vice President, Therapeutic Area Head, Oncology, Solid Tumor and Hematology at AbbVie, discusses new data ...
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