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

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

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.

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) ...

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

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 ...

Novo Nordisk said that the data suggests that the benefits of Wegovy go further than just weight loss in the patient population. Image credit: PJ McDonnell / Shutterstock.com. Novo Nordisk’s oral ...

Centessa is advancing ORX750 to pivotal trials based on the Phase IIa data. Image credit: SOPA Images /LightRocket via Getty Images Centessa Pharmaceuticals executives will be breathing a sigh of ...

In a Phase I trial, biomarkers seem to suggest the potential for a once or twice yearly dosing of Wave’s siRNA for weight loss.

While AstraZeneca's gefurulimab offered significant improvements to MG-ADL scores, it was bested by a variety of ...

The company’s stock rose significantly after it announced the full Phase I/II data. Image credit: Lightspring / Shutterstock.com. Intensity Therapeutics’ stock has risen nearly 400% after its oncology ...