Genmab’s Epcoritamab Plus Lenalidomide Meets Phase 3 Goal in Relapsed DLBCL
Genmab's epcoritamab plus lenalidomide achieved a 60% risk reduction in Phase 3 relapsed DLBCL trial, beating standard chemotherapy.
Sobi’s Gout CRL Is a Third-Party Manufacturing Indictment — And the Industry Wrote the Script
FDA issued Sobi a CRL for NASP on June 26, 2026, citing third-party manufacturing failures. Here's the operational breakdown...
FDA Approves Roflumilast Cream for Plaque Psoriasis in Children Age 2+
FDA approves roflumilast cream for plaque psoriasis in children as young as age 2, offering a steroid-free topical option...
VR Plus Neurostimulation Just Cleared a Major Feasibility Hurdle. Now Comes the Hard Part.
A Nature Medicine feasibility trial combining immersive VR with synchronous neurostimulation hit enrollment and kinematic endpoints in stroke rehab....
What Icon’s $300M Microsoft Bet Means for the Sites Running Their Trials
Icon's enterprise-wide Microsoft Copilot deployment and $300M AI investment will reshape how CRAs monitor, query, and escalate — here's...
Benchmark Scores Don’t Break. Clinical Reality Does. The Health AI Readiness Illusion.
Nature Medicine's frontier AI evaluation exposes a dangerous gap: models acing medical benchmarks collapse under adversarial pressure, and the...
Ipsen Acquires Kartos Therapeutics for $450M to Develop Navtemadlin for Myelofibrosis
Ipsen acquires Kartos for navtemadlin for myelofibrosis, an MDM2 inhibitor designed to help ruxolitinib non-responders. Phase III data expected...
Infigratinib Shows +2.1 cm/year Height Gain in Achondroplasia Trial
Infigratinib achondroplasia trial shows 2.1 cm/year height gain over placebo, with first-ever statistically significant body proportionality improvements in Pha
What the MASAI Trial Correspondence in The Lancet Actually Says About AI Screening Evidence
The Lancet correspondence on the MASAI trial exposes a core evidentiary gap: AI mammography's performance gains rest on intermediate...
What a 26-Trial Ketamine Meta-Analysis Gets Right, and What It Still Can’t Capture
A JAMA Psychiatry meta-analysis of 26 RCTs confirms ketamine's acute antidepressant effect. Here's what 1,166 trial patients don't show...