Safety

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.

News

The EMA has become the first regulator to link the use of Novo Nordisk's GLP-1 agonist semaglutide with sight-robbing disorder NAION.

News

Women in the UK taking weight-loss injections have been warned by the MHRA that they should make sure they are using effective contraception.

News

The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity.