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 ...