The planned study will enrol six to eight paediatric and adult patients with PSS in the US and Europe.

Japanese biotech drug aims to reverse tooth loss by regrowing teeth. Here's how TRG-035 works, where trials stand and when it ...

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The FDA’s new draft guidance on Bayesian methods in clinical trials has been hailed by some as a breakthrough that could speed drug development.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

Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter ...

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 ...

The Trump administration has released its latest unified agenda, laying out the proposed and final rules its agencies plan to ...

If you’ve turned on a television lately, chances are you heard a catchy jingle. One GLP-1 medication’s now-famous chorus, “Oh ...

FDA IND clearance permits a U.S. phase 2 registration-oriented trial of FG001 in high-grade glioma, with first-patient-in expected during Q2 2026. Fluorescence-guided surgery with FG001 aims to ...

By Puyaan Singh June 29 (Reuters) - The New England Journal of Medicine on Monday retracted an article on a pivotal clinical ...

The U.S. Food and Drug Administration (FDA) is moving to speed drug development and review by launching real-time clinical trials. The move could soon mean more options for patients who need ...

By Deena Beasley June 30 (Reuters) - The chair of the U.S. House Select Committee on China opened national security ...