Safety

News

FDA probing cancer cases with Bluebird's CALD gene therapy

The FDA is scrutinising reports of haematological cancers in patients treated with bluebird bio's Skysona gene therapy for neurological disease CALD

News

Neurogene drops high-dose arm in Rett study after death

The patient affected by a serious adverse event in Neurogene's clinical trial of Rett syndrome gene therapy has now died

News

Neurogene falls again on Rett gene therapy side effects

Neurogene has halted patient enrolment in the high-dose arm of its trial of Rett syndrome gene therapy, sparking another run on its shares.

News

Amgen plays down safety concern with obesity candidate

Amgen has rebuffed claims made by an analyst suggesting that its obesity drug MariTide is associated with reductions in bone mineral density that could undermine its ability to compete in t

News

Lilly touts new Kisunla regimen that reduces side effects

Eli Lilly says a new starting dose regimen for its Alzheimer's disease therapy Kisunla reduces the risk of side effects that have stood in the way of approvals and reimbursement decisions f

Digital

illustration of AI style auto generation flow diagram

Could GenAI auto-generate entire regulatory dossiers?

Generative AI (GenAI) technology is already transforming everyday regulatory and safety processes, thanks to its ability to digest, assess, and summarise key insights and findings from acro