Eli Lilly has now submitted a new drug application (NDA) for GLP-1RA orforglipron to the FDA for use in adults with obesity.

Lilly is investigating the triple G agonist retatrutide in seven other Phase III trials, which are due to read out in 2026.

The FDA has delayed tolebrutinib’s review date again, as Sanofi also posted a Phase III failure for the MS candidate.

Anova Enterprises has launched the AnovaOS SaaS platform, a new AI-based patient matching solution for clinical trials.

MajesTEC-3 gives J&J a way to keep Darzalex relevant beyond its 2029 patent cliff. Credit: aipicte via Shutterstock. At the American Society of Hematology (ASH) Annual Meeting 2025, held in Orlando, ...

Capricor’s stock shot up by 371% after it announced the HOPE-3 data. Image credit: Lightspring / Shutterstock.com. Capricor Therapeutics’ stock has soared by more than 370% after a pivotal trial of ...

The safety profile of atogepant over the 24-week period aligned with earlier studies of its use in migraine prevention, with no new safety signals observed. Credit: Komsan Loonprom / Shutterstock.com.

The FDA has debuted a framework that is designed to help companies move away from the use of non-human primate preclinical toxicology testing. Image credit: Deniz_Guler via Shutterstock.com. The US ...

Immunome’s acquired gamma secretase inhibitor, varegacestat, has demonstrated its efficacy and tolerability in a Phase III study, meaning the company will now file for the drug’s approval with the FDA ...

Spinogenix’s first-in-class ALS treatment, SPG302 has been shown to slow disease progression in 82% of patients during a Phase IIa study. Image credit: David Herraez Calzada via Shutterstock.com.

Produodopa is an alternative to AbbVie’s own Duodopa. Credit: Michael Vi via Shutterstock. On 9 January 2024, AbbVie announced the launch of Produodopa ...

AI technology in clinical trials has the potential to speed up cohort selection and patient recruitment. However, data management and inherit bias in datasets need to be addressed first.