Psychedelic Trials Need Better Blinding: What UMBRAA Could Contribute
A JAMA Psychiatry Viewpoint proposes UMBRAA: multidrug active placebos plus authorized incomplete disclosure. It is untested, but the problem...
Extension Studies Are Not Optional Data, They’re the FDA’s Long-Term Safety Net
JAMA's new analysis shows extension studies catch delayed adverse events and durability gaps that Phase 3 trials structurally cannot,...
QIAGEN Selects Medrio EDC for In Vitro Diagnostic Studies
QIAGEN selects Medrio EDC to streamline in vitro diagnostic studies with cost control and internal form configuration capabilities.
Icotrokinra meets ACR20 endpoint in Phase 3 psoriatic arthritis trial
Icotrokinra meets ACR20 endpoint in Phase 3 psoriatic arthritis trial, with 58% of biologic-naive patients achieving response at Week...
The FDA’s AAV Approval Playbook Has Gaps That Could Define the Next Decade of Gene Therapy
FDA's reviews of Zolgensma, Luxturna, and Hemgenix reveal critical gaps in AAV trial design, CMC standards, and long-term safety...
Semaglutide 2.4 mg Shows Greater Weight Loss Than Resmetirom in MASH
Semaglutide 2.4 mg showed significantly greater weight loss and liver enzyme improvements than resmetirom in real-world MASH studies presented...
EMA’s PRAC October 2026 Review of Deanxit Signals Tightened Scrutiny on Fixed-Dose CNS Combination Products
EMA's PRAC launched a Deanxit safety review on Oct 16, 2026, citing serious neurological and psychiatric adverse events, here's...
ICON’s FIRECREST Platform Cuts Video Production Time by 90% With New AI Engine
ICON's AI-directed video engine cuts clinical trial video production time by 90%, streamlining site selection and training across 500,000+...
Citius Oncology Presents LYMPHIR Quality-of-Life Data at EORTC Meeting
Citius Oncology presents LYMPHIR quality-of-life data from pivotal Study 302 at EORTC meeting, supporting formulary discussions with European payers.
ATG-201 Phase I trial opens in China for B cell autoimmune diseases
ATG-201 Phase I trial opens in China for B cell autoimmune diseases, testing a CD19×CD3 bispecific with masking technology...