IMAAVY meets primary endpoint in Phase 2/3 warm autoimmune hemolytic anemia trial
Nipocalimab met its primary endpoint in the Phase 2/3 ENERGY trial for warm autoimmune hemolytic anemia, with nearly two-thirds...
Novartis del-brax meets primary endpoints in FSHD Phase I/II study
Novartis del-brax Phase I/II study met primary endpoints, reducing KHDC1L and creatine kinase in FSHD patients over 12 months...
Health Canada Grants Priority Review to Italfarmaco’s Givinostat for Duchenne Muscular Dystrophy
Health Canada grants Priority Review to Italfarmaco's Givinostat for Duchenne muscular dystrophy, with a 180-day regulatory decision target by...
Single-Cell Spatial Pharmacobiology Just Changed What “Drug Delivery” Means in Solid Tumor Trials
A Nature Biotechnology study using Single-cell Spatial Pharmacobiology exposes heterogeneous antibody delivery in solid tumors—what sponsors assumed about…
Why Pilots Don’t Scale: The Case for Pre-Protocol Invariants in Clinical Development
A leading sponsor hit 79% site adoption and called it a ceiling. The fix isn’t better tools—it’s pre-protocol invariants...
Kymera’s KT-485 Enters Phase 1 Trial Under $20M Sanofi Deal
Kymera's KT-485 enters Phase 1 testing for hidradenitis suppurativa under a $20M Sanofi partnership with up to $975M in...
TG Therapeutics Begins Phase 2 Trial of BRIUMVI in Myasthenia Gravis
TG Therapeutics launches Phase 2 trial of BRIUMVI in myasthenia gravis, testing sequential therapy with efgartigimod for sustained B-cell...
FDA Approves Lilly’s EBGLYSS for Every-Eight-Week Dosing in Atopic Dermatitis
FDA approves every-eight-week dosing for Lilly's EBGLYSS in atopic dermatitis, reducing injections to six per year for adults and...
When Your CRO Gets Acquired Mid-Trial, the Site Pays the Operational Price
Tevogen Bio's MSO/CRO acquisition push signals a consolidation wave that will disrupt site activation, monitoring, and contracts mid-study. Here's...
Ten Years of EMA Post-Authorization Data Reveal a System Running on Incomplete Evidence
A Nature Reviews Drug Discovery analysis of EMA post-authorization studies exposes systematic gaps in how conditional approvals convert to...