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.

At the European Society for Medical Oncology (ESMO) 2025 event, held in Berlin, Germany, between 17-21 October, Celcuity ...

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) ...

The study included subjects aged between four and ten years for the treatment of Rett syndrome. Credit: Yuriy K / Shutterstock.com. Neurogene has announced encouraging interim clinical data in the ...

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 ...

The trial enrolled 73 subjects who had not responded satisfactorily to a minimum of one antidepressant during their current episode. Credit: daniiD / Shutterstock.com. Neurocrine Biosciences has ...

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 ...