Denecimig shows consistent safety and efficacy across age groups in hemophilia A trial
Denecimig demonstrates consistent safety and efficacy across age groups in hemophilia A trial, with 89% of children achieving zero...
Checkpoint Inhibitors Are Failing Recurrent GBM. This Phase 1 Trial Design May Explain Why They Keep Trying.
A 46-patient LAG-3/PD-1 phase 1 trial in recurrent GBM reveals the protocol innovations sponsors need before scaling immunotherapy in...
FDA’s Single-Trial Default: What It Actually Means for Your Protocol Strategy
FDA made a single pivotal trial its default approval standard on Feb. 19, 2026. Here's what clinical ops leaders...
The Serotonin Signal Hiding in Plain Sight Across Two Rapid-Acting Depression Treatments
A Bayesian PET re-analysis finds ketamine and ECT both upregulate 5-HT1B receptors, pointing to a shared biomarker that TRD...
INmune Bio’s XPro Shows Significant Brain Imaging Changes in Early Alzheimer’s Trial
INmune Bio's XPro demonstrates statistically significant changes in white matter and gray matter microstructure at 24 weeks in early...
Fate Therapeutics Gets FDA Clearance for FT839 Autoimmune CAR-T Therapy
Fate Therapeutics receives FDA clearance for FT839 autoimmune CAR-T therapy, a dual-targeted allogeneic cell product designed to treat rheumatoid...
The Trial Without Walls: How Real-World Evidence Is Rewriting the Rules of Drug Approval
Nature Medicine's RWE trial emulation framework is reshaping FDA approval pathways. Here's what sponsors running traditional RCTs need to...
Satellos’ SAT-3247 Shows Muscle Fat Reduction in DMD Adults at Six Months
SAT-3247 showed muscle fat reduction in DMD adults at six months, with participants displaying improved upper limb function and...
Setmelanotide Phase 3 Trial for Hypothalamic Obesity Published in NEJM
Setmelanotide Phase 3 Trial achieves 19.8 percentage-point BMI reduction in hypothalamic obesity, published in NEJM following FDA approval.
When Two CROs Become One, Sites Pay the Integration Tax
Caidya and Simbec-Orion's June 2026 merger creates real site-level friction: dual CTMS logins, monitoring model gaps, and budget renegotiations...