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...
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...
There’s a concerning number of Australians living with a dangerous heart rhythm disorder - and many of them have no idea. Atrial fibrillation (AF) is a condition most people have never heard of and that’s a big problem, because it is already a silent cause of stroke. ...
The weight-loss revolution that began with Ozempic and Wegovy is entering a more crowded and competitive phase, and the field of late-stage obesity drugs has become the most closely watched area in pharmaceutical research. Two recent milestones show how fast the...
The Menarini Group and Karyopharm Therapeutics report that selinexor plus ruxolitinib improves spleen response over standard monotherapy in the Phase 3 SENTRY trial in myelofibrosis, Agios Pharmaceuticals reinforces the anti-hemolytic profile of mitapivat with new...
Sanofi has halted a late-stage trial of its experimental complement inhibitor riliprubart in chronic inflammatory demyelinating polyneuropathy (CIDP), a setback that analysts say could create volatility across the wider complement inhibitor field. The company said in...
Survodutide delivers dual Phase 3 success in obesity and metabolic liver disease at ADA 2026, secukinumab becomes the first targeted biologic to demonstrate sustained remission in polymyalgia rheumatica, dapirolizumab pegol meets its Phase 3 primary endpoint in...
For decades, the landscape of clinical research was dominated by fixed, traditional trial designs. In these legacy studies, the primary objective was often maintaining a strict, unchanging protocol from inception to conclusion. But the landscape of modern medicine has...