The clinical trial results 25 September 2026 span Sjögren’s, urticaria, IgA nephropathy, obesity, cutaneous lupus and Alzheimer’s psychosis. Amgen’s dazodalibep met its primary endpoint in systemic Sjögren’s disease. Celldex’s barzolvolimab met its primary and all key...
Definium Therapeutics’ DT120 meets its primary endpoint in the Phase 3 Panorama study in generalised anxiety disorder, AstraZeneca’s camizestrant misses its primary endpoint in the Phase III SERENA-4 study in first-line breast cancer, Vera Therapeutics’ atacicept cuts...
Trutakna two-year ORIGIN 3 data put Vera in the IgAN full approval race. What was reported, what was left out, and where UK access stands.
The FDA opened applications for its expedited IND pilot on 15 September 2026. Its criteria favour US trials, while the MHRA 14-day Phase 1 route excludes first-in-human studies.
Two B7-H3 ADC trials beat topotecan in relapsed small cell lung cancer at WCLC 2026, but both ran only in China and neither is a filing package.
In October 2025, the FDA approved an anti-CD20 monoclonal antibody for adults with active lupus nephritis receiving standard therapy. In the phase 3 REGENCY trial, 46.4% of patients receiving B-cell depletion plus standard therapy achieved a complete renal response at...
Tenax Therapeutics' TNX-103 misses its primary endpoint in the Phase 3 LEVEL trial in pulmonary hypertension due to heart failure with preserved ejection fraction, AbCellera's ABCL635 meets both primary efficacy endpoints in a Phase 2 trial in menopausal vasomotor...
Europe’s changing macroeconomic and regulatory environment is prompting the medtech industry to rethink clinical processes and technologies. New insights reveal focus on establishing a unified digital foundation as medtech companies look to optimise data strategy,...
Merck’s tulisokibart meets its primary and key secondary endpoints in a Phase 2 hidradenitis suppurativa study but misses in systemic sclerosis-associated interstitial lung disease, Eli Lilly’s olomorasib receives a second FDA Breakthrough Therapy designation in KRAS...
The ziltivekimab ZEUS trial has produced one of the more instructive negative results in recent cardiovascular medicine. Novo Nordisk announced headline results on 31 July 2026 showing that its once-monthly interleukin-6 inhibitor ziltivekimab lowered inflammation...
An FDA advisory committee votes against Capricor Therapeutics' deramiocel in Duchenne muscular dystrophy cardiomyopathy, Pfizer's ritlecitinib meets its co-primary endpoints in two Phase 3 nonsegmental vitiligo trials, Karyopharm Therapeutics' selinexor misses its...
Merck's enlicitide receives FDA approval as the first oral PCSK9 inhibitor for adults with hypercholesterolaemia, GSK's zidesamtinib earns FDA approval as a next-generation ROS1 selective inhibitor for previously treated non-small cell lung cancer, GSK's camlipixant...
Celcuity's gedatolisib receives FDA approval as the first pan-PI3K and mTOR inhibitor for advanced breast cancer, Biogen's diranersen delivers detailed Phase 2 CELIA data showing tau reduction and cognitive benefit in early Alzheimer's disease, Novo Nordisk's...
Roche’s divarasib demonstrates superiority over approved KRAS G12C inhibitors in the Phase 3 Krascendo 1 head-to-head lung cancer trial, Vera Therapeutics’ Trutakna receives FDA accelerated approval as the first BAFF/APRIL inhibitor for IgA nephropathy, Rhythm...
Every therapy that reaches a patient first has to clear a quieter hurdle that rarely makes headlines: finding enough of the right people to test it. That hurdle is where most clinical programs stumble. Roughly 80% of clinical trials fail to meet their enrollment...
The US Food and Drug Administration has approved Tregzi, a regulatory T-cell therapy developed by Orca Bio. It is the first treatment built from highly purified regulatory T cells to reach the American market. The FDA cleared Tregzi on 30 June 2026. It is designed to...
Genmab and AbbVie's epcoritamab meets its primary endpoint in a Phase 3 trial for relapsed or refractory diffuse large B-cell lymphoma, the FDA approves Orca Bio's Tregzi as the first regulatory T-cell therapy to reduce chronic graft-versus-host disease in blood...
This week's clinical trial results for 26 June 2026 deliver a landmark psychiatric result, a major oncology setback, and a decisive blow to one of the most watched platforms in regenerative medicine. Definium Therapeutics' DT120 becomes the first lysergide therapy to...