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, the first regulatory package for this orphan condition with...

MAMS platform trials could slash neurodegenerative drug development timelines—so why are sponsors still running serial Phase 2s for Alzheimer's...

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. A 20-patient Phase 2a study tests whether this immune...

BXCL501 reduced agitation versus placebo across mild, moderate, and severe cases in a 12-week home-based Phase 3 trial, with...

Resmetirom reduces cardiovascular and liver risk markers in MASH patients, with 49% achieving significant liver stiffness improvement within nine...

TG Therapeutics' ublituximab meets primary endpoint in Phase 3 RMS trial, enabling single-visit initiation dosing versus competitors.

Sacituzumab tirumotecan plus pembrolizumab cuts NSCLC progression risk by 65% in OptiTROP-Lung05 trial, with median PFS not reached versus...

Zenas BioPharma files BLA for obexelimab in IgG4-Related Disease with 56% flare reduction versus placebo over 52 weeks.