Safety

News

Eli Lilly has won FDA approval for a new regimen for its Alzheimer's disease therapy Kisunla, which carries a reduced risk of side effects.

News

There is enough experience with the first wave of autologous CAR-T therapies to allow strict rules ensuring their safe use to be relaxed, says FDA.

News

The UK is studying cases of pancreatitis in people taking GLP-1 drugs for weight loss or type 2 diabetes to see if genetics may make them vulnerable.

News

The FDA has launched a formal investigation into two liver failure-related deaths in patients treated with Duchenne gene therapy Elevidys.

News

Major changes to medical device regulations in the UK have come into force with an overhaul of post-market surveillance requirements.

News

Another death from liver failure has been seen with Roche and Sarepta's Duchenne muscular dystrophy therapy Elevidys, prompting a pause on treatment.