Nuvalent is also investigating the drug in a Phase III trial in TKI-naive ALK-positive NSCLC patients. Image credit: Piotr Swat / Shutterstock.com. Nuvalent’s stock price oscillated after it’s ...

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.

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 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 ...

Your essential news briefing covering clinical trials, research, and drug development from conception to pre-FDA approval.

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 ...

Novartis announced the termination in its Q2 2025 earnings. Image credit: Melnikov Dmitriy / Shutterstock.com. Novartis is stopping the development of ianalumab in hidradenitis suppurativa (HS) after ...

Recently, artificial intelligence (AI) has been paving the way and helping sponsors with patient identification and participant retention. Digital twins, a new technological frontier in the AI space, ...

Mounjaro™ (tirzepatide) is a first-in-class GIP and GLP-1 receptor agonist for treating type 2 diabetes. Approved in the US, Europe, Australia, Canada and Japan Mounjaro™ (tirzepatide) injection is a ...

Almost three decades ago, the FDA allowed women back into clinical research to participate as subjects, but the representation of females remains an issue, especially in Phase I trials. A recent study ...