Why a fundamental reimagining of how clinical studies operate is still necessary to achieve a true paradigm shift—and shed ...

By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often ...

The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the ...

Applied Clinical Trials is the thought leader in pharmaceutical drug development operations and clinical trial design, management, and monitoring.

Results from the Phase III EMBARK trial show that in combination with leuprolide, Xtandi (enzalutamide) demonstrated a ...

In the P304 Phase III study, Moderna’s mRNA-1010 demonstrated a 26.6% relative efficacy over a standard-dose flu vaccine in adults aged 50+, showing consistent protection across strains and age groups ...

Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, ...

In final data from the Phase III ENLIVEN study, Turalio (pexidartinib) demonstrated durable tumor responses and a consistent ...

Outdated regulations and inflexible sponsor processes are hampering clinical trial recruitment, but empowering sites with ...

In this video interview, Heather Horville, solutions consultant at Greenphire, explains how upfront reimbursement, travel stipends, and flexible support services can empower more patients—especially ...

The Phase I/IIa CLARICO trial of OpCT-001 marks the first clinical trial of an investigational induced pluripotent stem ...

Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, ...