Obexelimab Reduces IgG4-RD Flare Risk 56% in Phase 3 INDIGO Trial
Phase 3 INDIGO Trial shows obexelimab reduced IgG4-RD flare risk by 56% while lowering steroid burden and adverse events...
Roche to Present Giredestrant Data on Menopausal Subgroups at ASCO 2026
Roche presents giredestrant data on menopausal subgroups at ASCO 2026, revealing efficacy consistency across pre- and post-menopausal breast cancer...
The IT Neuron Finding That Should Reshape How We Design Rapid-Acting Depression Trials
New Cell data pinpoints intratelencephalic neurons in the anterior insula as the mechanistic key to aiTBS antidepressant effects—here's what...
Aardvark’s Clinical Hold Isn’t Bad Luck — It’s a Pre-Clinical Characterization Failure
FDA placed a full clinical hold on Aardvark's ARD-101 after a cardiac event in a healthy volunteer. Here's what...
NBTXR3 Shows 57% Complete Response Rate in Stage III Lung Cancer Trial
NBTXR3 achieved a 57% complete response rate in a stage III lung cancer trial, compared to fewer than 5%...
The Nacubactam Trials Just Proved Something the FDA Needs to Hear About AMR Drug Development
Integral-1's Phase 3 results for cefepime–nacubactam vs. imipenem show 89% composite cure rates — and a regulatory blueprint AMR...
Quince’s LAM-001 Shows Pulmonary Vascular Resistance Reduction in PH-ILD Patients
LAM-001 demonstrated a 33.9% reduction in pulmonary vascular resistance in PH-ILD patients, prompting Quince Therapeutics to advance to Phase...
UroGen’s UGN-103 Shows 94.5% Six-Month Response in NMIBC Trial
UroGen's UGN-103 demonstrates 94.5% six-month response in bladder cancer trial, offering simplified manufacturing over existing ZUSDURI therapy.
Roche’s giredestrant shows 30% reduction in breast cancer recurrence at ASCO 2026
Roche's giredestrant demonstrates 30% reduction in breast cancer recurrence or death in the lidERA trial, with FDA filing implications...
Regeneron’s Fianlimab Misses Primary Endpoint in Phase 3 Melanoma Trial
Regeneron's fianlimab misses primary endpoint in Phase 3 melanoma trial, posting p-value of 0.0627 despite 5.1-month PFS improvement over...