Nuvalent will discuss the data for TKI pre-treated ALK-positive NSCLC patients with the FDA in a pre-NDA meeting ...

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.

Contineum Therapeutics’ M1 antagonist, PIPE-307, has failed to meet its primary and secondary efficacy endpoints in a Phase II trial in RRMS. Image credit: Andrzej Rostek via ShutterStock.com.

The trial is evaluating sabirnetug for early Alzheimer’s disease. Credit: Dragana Gordic / Shutterstock.com. Acumen Pharmaceuticals has dosed the first subject in the open-label extension (OLE) ...

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 ...

Amid geopolitical instability, professionals in the clinical trials segment must look to mitigate risks early through operational flexibility. Image credit: Athanasios Psimadis / Arena International.

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 ...

Whether you are new to clinical research agreements or a contracts ninja, at any given moment there is at least one agreement you can think of that could have been worded differently. Or a clinical ...

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 ...