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.

Despite the trial failure, Sarepta will still seek full approval of AMONDYS 45 and VYONDYS 53 in DMD from the FDA.

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

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) ...

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 ...

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 ...

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

The double-adjuvant arms produced significantly higher neutralising antibody titres on days 43 and 57 compared to the single-adjuvant arm. Credit: AnnaStills / Shutterstock.com. Valneva has reported ...