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 ...

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

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.

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

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 ...

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 ...

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

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, ...

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 ...

After the Lykos rejection last year, companies have started looking at their trial designs to avoid the same difficulties. Image credit: eamesBot / Shutterstock. In 2024, Lykos Therapeutics looked set ...

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 ...