At OCT DACH 2025, industry members noted that the implementation of AI in clinical trials must be carefully thought out.

Gene anticipates filing a biologics licence application (BLA) for detalimogene voraplasmid to the FDA in H2 2026.

If Roche's fenebrutinib got the FDA go-ahead, it would become the first BTK inhibitor to gain approval in both RMS and PPMS.

Whether you are new to clinical research agreements or a contracts ninja, at any given moment there is at least one agreement you can think of that could have been worded differently. Or a clinical ...

Alkermes announced that the drug met its dual primary endpoints, however this was only in the two high dose cohorts and the data was “adjusted for multiplicity”. Image credit: MediaNews Group / Boston ...

Each insight is focused on improving human-centred outcomes, aiming to cut the burden on both subjects and research sites. Credit: metamorworks / Shutterstock.com. WCG has introduced Data & Insights ...

The potential of digital twin technology is growing within the clinical trials landscape. Image credit: Gorodenkoff via ShutterStock.com. In recent years, automation and artificial intelligence (AI) ...

If approved in AFRS, it would become the ninth US approved indication for Dupixent. Image credit: Angelina Avei / Shutterstock.com Sanofi and Regeneron’s Dupixent (dupilumab) could be set for its ...

The WHO will support initiative implementation, foster dialogue, and mobilise resources for priority research with Member States and stakeholders. Credit: Richard Juilliart / Shutterstock.com. The ...

Sarepta has contended with the FDA on a number of occasions in 2025 after patient deaths following administration of its DMD gene therapy. Image credit: Cassandra Klos / Bloomberg via Getty Images.

The Phase I clinical trial will assess RP-3467 as a potential treatment for various solid tumours. Credit: Vink Fan/Shutterstock. Repare Therapeutics has dosed the first subject in its Phase I POLAR ...