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.

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

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) ...

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 ...

Intellia Therapeutics said the patient death occurred on 5 November 2025. Image credit: Universal Images Group Editorial / Universal Images Group via Getty Images. A patient dosed with Intellia ...

The trial aims to provide safety and efficacy data for submissions to regulatory agencies in the US and Europe. Credit: rathshiki / Shutterstock.com. Vir Biotechnology has concluded subject enrolment ...

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 ...

Accurately tracking trial initiations has often been a challenge because start dates are not always disclosed or are reported incorrectly. Credit: Ihar Halavach via Shutterstock.com. According to ...