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.

If Roche's fenebrutinib got the FDA go-ahead, it would become the first BTK inhibitor to gain approval in both RMS and PPMS.

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

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 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 ...

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 ...

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 ...

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 ...

Sharp Services, a leader in pharmaceutical packaging, clinical trial services and sterile manufacturing has announced a $100 million investment across its global facility network to address increasing ...

Isomorphic Lab’s AlphaFold 3 system, developed with Google DeepMind, won its developers a Nobel Prize. Image credit: Shutterstock / Robert Way Alphabet’s AI drug development subsidiary Isomorphic Labs ...