Adagrasib confirmatory trial fails in colorectal cancer, approval at risk
Adagrasib confirmatory trial fails to meet primary endpoint in second-line KRAS G12C colorectal cancer, putting FDA approval at risk.
Pfizer’s Elranatamab Meets Phase 3 Goal in Multiple Myeloma
Pfizer's elranatamab clears Phase 3 progression-free survival endpoint in multiple myeloma, signaling potential expansion into earlier disease settings.
Survodutide Achieves 17% Weight Loss in Phase 3 Obesity Trial
Survodutide achieves 17% weight loss in Phase 3 obesity trial, with distinct body composition benefits compared to existing GLP-1...
FDA Oncology Panel Rejects AstraZeneca’s Novel Trial Design Framework, 6-3
FDA oncology panel votes 6-3 to reject AstraZeneca's novel trial design framework for breast cancer drug approval, signaling stricter...
FDA Places Clinical Hold on Newron’s Evenamide Schizophrenia Trial After Patient Death
FDA clinical hold placed on Newron's evenamide schizophrenia trial following a patient death during Phase 3 enrollment.
The Eight Hours Clinicians Ignored: How Albus Health Is Turning Sleep Into a Clinical Endpoint
Mikesh Udani CEO, Albus Health For decades, respiratory medicine has measured what patients do during the day—spirometry in clinic,...
The Disease-Modification Bet in Pulmonary Arterial Hypertension
Sten R. Sörensen CEO and Board Member, Cereno Scientific Pulmonary arterial hypertension kills most patients within seven years of...
NMN in ITP: A Phase 1/2 Signal That Should Rewrite How We Design Rare Disease Trials
A phase 1/2 NMN trial in immune thrombocytopenia just posted a clean safety signal and platelet response data that...
Pioneering BCI Lets Stroke Patient Control PC With His Mind
A fully implanted, wireless brain-computer interface enabled a post-stroke participant to control a computer, including a functional Pong task,...
First Patient Enrolled in AXPALXI™ Wet AMD Extension Trial
Ocular Therapeutix has enrolled the first participant in SOL-X, a 36‑month open-label extension study evaluating long-term safety and outcomes...