Safety

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

News

Pfizer pulls sickle cell med Oxbryta off market after deaths

Pfizer is voluntarily withdrawing its sickle cell disease (SCD) therapy Oxbryta from all world markets after finding an "imbalance" in deaths in its clinical trials programme.

News

J&J tries to push talc bankruptcy over the line once again

Johnson & Johnson's long-running effort to put litigation claiming its talc products caused cancer has continued with a third attempt to place a subsidiary company into bankruptcy.

News

J&J sweetens controversial talc settlement deal

In a bid to put litigation over the safety of its talc products into the rearview mirror, Johnson & Johnson has added another $1.1 billion to its settlement offer, according to media re

News

Study reignites debate on GLP-1 drugs and suicide risk

A study has found a higher risk of suicidal thoughts in users of Novo Nordisk's GLP-1 agonist-based drugs for diabetes and obesity, even though regulators in the US and EU concluded there w