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

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

The approval follows a review of updated clinical documentations, including the investigator brochure, amended protocol, and information from the participants. Credit: mojo cp/Shutterstock.com.

In earlier Phase I/II data, microdystrophin concentration ranged from 20% to 122% after the pivotal dose. Credit: Sai Thaw Kyar / Shutterstock.com. REGENXBIO has concluded enrolment of subjects in the ...

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 ...

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

Recently, artificial intelligence (AI) has been paving the way and helping sponsors with patient identification and participant retention. Digital twins, a new technological frontier in the AI space, ...

The trial will enrol 300 chronic low back pain patients with inflammatory degenerative disc disease of less than five years duration. Credit: Anatoliy Cherkas / Shutterstock. Australia-based Mesoblast ...

It’s only been a month since the Ukraine war started, yet thousands of lives have been lost, millions have fled into neighbouring countries, and innumerable infrastructure destroyed. In terms of ...

Almost three decades ago, the FDA allowed women back into clinical research to participate as subjects, but the representation of females remains an issue, especially in Phase I trials. A recent study ...

The pipeline continues to look strong for HIV but the hunt for a cure or vaccine continues. Image credit: Shutterstock / PENpics Studio The year 2023 started with disappointing news for the field of ...