BioXcel’s BXCL501 Shows Efficacy Across Severity Levels in At-Home Agitation Trial
BioXcel's BXCL501 shows efficacy across severity levels in at-home agitation trial, with sustained benefit over 12 weeks of repeated...
GammaTile Shows 26-Point Survival Gain Over Surgery Alone in Brain Metastases Trial
ROADS phase 3 trial shows GammaTile intraoperative brachytherapy achieved 61.7% 24-month survival versus 35.7% for surgery plus radiotherapy in...
GRAIL’s Galleri Trial Misses Primary Endpoint but Shows Stage IV Cancer Reduction
GRAIL's Galleri trial missed its primary endpoint for combined Stage III/IV cancer reduction but showed 26% Stage IV reduction...
Pumitamig shows 72.7% response rate in Phase 2 squamous NSCLC trial
Pumitamig achieves 72.7% response rate in Phase 2 squamous NSCLC trial, with 100% disease control across evaluable patients.
Sacituzumab tirumotecan plus pembrolizumab meets primary endpoint in lung cancer trial
Sacituzumab tirumotecan plus pembrolizumab meets primary endpoint in lung cancer trial with 0.35 hazard ratio for progression-free survival.
Zenas BioPharma Submits Obexelimab BLA to FDA for IgG4-Related Disease
Zenas BioPharma submits obexelimab BLA to FDA for IgG4-Related Disease, the first regulatory package for this orphan condition with...
The Neurodegenerative Trial Problem Has a Design Solution—But Sponsors Keep Ignoring It
MAMS platform trials could slash neurodegenerative drug development timelines—so why are sponsors still running serial Phase 2s for Alzheimer's...
FDA’s May 2026 Leadership Exodus: What the Simultaneous CDER and CBER Vacancies Mean for Sponsor IND Strategy
With Makary out May 12 and acting CDER chief Høeg fired May 15, sponsors with pending NDAs and INDs...
FDA Clears IND for EOM613 Trial in Cancer Cachexia Patients
FDA clears IND for EOM613 trial in cancer cachexia patients. A 20-patient Phase 2a study tests whether this immune...
BXCL501 Shows Efficacy Across Agitation Severity in Phase 3 At-Home Trial
BXCL501 reduced agitation versus placebo across mild, moderate, and severe cases in a 12-week home-based Phase 3 trial, with...