EMA Reports Near-Record 104 Medicine Approvals in 2025 with Strategic Focus on Cardiovascular Health
The European Medicines Agency (EMA) convened a comprehensive press briefing to dissect the regulatory milestones of 2025, a year...
Krystal Biotech Confirms CFTR Delivery in Phase 1 CF Study
In the highest-dose cohort of its Phase 1 CORAL-1 study, Krystal’s inhaled gene therapy KB407 achieved confirmed airway transduction...
COACH Trial Confirms Durable Benefits in Achondroplasia
Topline at 52 weeks from Ascendis’ Phase 2 COACH study in pediatric achondroplasia showed mean annualized growth velocity of...
Benitec BB-301 Trial Shows Positive Long-Term Efficacy
Topline data: In Benitec’s Phase 1b/2a OPMD study, the first treated patient showed sustained and deepening benefit at 24...
Data Gluttony? Why Big Pharma is Addicted to 5.9 Million Useless Clinical Trial Datapoints
The lead site coordinator stared at the tablet, then at the patient, then back at the tablet. They were...
Phase 1 Trial of AGENT-797 to Prevent Graft-vs-Host Disease
MiNK Therapeutics will open an investigator-sponsored Phase 1 trial of its off-the-shelf iNKT cell therapy, agenT-797, in allogeneic hematopoietic...
Marius Pharma to Study Kyzatrex in Men Ages 65-80
In its prior Phase 3 program, KYZATREX achieved normal 24-hour mean total testosterone levels in 88% of treated hypogonadal...
U of T Study: Real-Time Brain Fluid Modulation with Light
A brief, 4-minute session of near-infrared photobiomodulation produced immediate fMRI-detected shifts in cerebrospinal fluid dynamics in healthy adults, including...
ALX Oncology Advances Trials for Evorpacept and ALX2004
No dose-limiting toxicities have been observed to date in ALX Oncology’s first-in-human study of its EGFR-targeted ADC ALX2004, which...
ACTG Launches iPACE-HIV Study on Frailty Intervention
ACTG has opened enrollment for A5426 (IPACE-HIV), a Phase 2, double-blind, randomized study testing the senolytic combination of dasatinib...
