The decision follows the FDA’s review of an interim safety report for the first three patients treated in the trial.

Federal drug officials are aiming to significantly reduce the timeline for new drug development by launching real-time ...

A new drug targets RAS cancer-causing cells in the pancreas, nearly doubling survival rates in clinical trials. Here's how ...

Following the pre-specified interim safety report and overwhelming demand from clinicians to treat patients as quickly as possible, Alpha Tau ...

FDA clearance allows Imviva to test CTA313, an off-the-shelf CAR T-cell therapy, in progressive MS and other autoimmune ...

Why does it take a new drug 10 years, on average, to come to market? Part of the reason lies in the dead time in the process. Historically, trials have required tedious tabulations and repeated ...

The first-of-its-kind pilot could lead to speedier regulatory approval of medical drugs and devices and potentially reduce “20, 30, 40% of overall clinical trial time,” according to FDA Chief ...

The FDA’s new draft guidance on Bayesian methods in clinical trials has been hailed by some as a breakthrough that could speed drug development. But statisticians and researchers are divided on ...

The US Food and Drug Administration has launched a Real-Time Clinical Trials pilot with AstraZeneca and Amgen to speed safety and efficacy reporting in oncology studies. Using Paradigm Health’s ...

June 12 (Reuters) - Jazz Pharmaceuticals said on Friday its lung cancer drug Zepzelca failed to meet the main goal of ...

The US Food and Drug Administration (FDA) laid out its recommendations for sponsors to study multiple versions of a cellular or gene therapy in a clinical trial for a single disease. The agency said ...

A new study finds just 6% of clinical trials used to approve new drugs in the U.S. reflect the country's racial and ethnic makeup, with an increasing trend of trials underrepresenting Black and ...