GSK will be filing for approval of bepirovirsen in hepatitis B to global regulatory authorities based on the Phase III data.

More than two years after the FDA held a public workshop on measuring overall survival (OS) in clinical cancer trials, the agency has released a draft guidance on the topic, recommending that OS be ...

Database locks for studies on actinic keratosis (AK) and acne vulgaris achieved on January 5, 2026Data generated will support key regulatory ...

New Pharmacokinetic (PK) and Pharmacodynamic Data from Sub-Study in Phase III Trial Strengthens Scientific Basis for RenovoRx ...

Ascletis Pharma has received investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) to begin ...

Under the new leadership of Marty Makary, the FDA should focus more attention on the critical role of real-world clinical data — such as from health insurance databases — in the ongoing assessment of ...

Zoldonrasib targets KRAS G12D-mutated non-small cell lung cancer, receiving FDA breakthrough therapy designation for its ...

A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...

To sum up, GH001 has shown us pretty robust efficacy, a strong safety profile, and durable antidepressant effects. Going into ...

Please provide your email address to receive an email when new articles are posted on . FDA issued guidance on decentralized elements of clinical trials last fall. Investigators need to balance using ...