Ipsen has said that it plans to file a new marketing application for its treatment for itch in Alagille syndrome (ALGS), Bylvay, after failing to persuade an EMA committee
The EMA will kick off a review of Astellas and Pfizer's prostate cancer therapy Xtandi in an earlier-stage form of the cancer, which if approved could give the product a l
The EMA has endorsed a digital measurement using wearables developed by Sysnav Healthcare as a primary endpoint for use in trials involving patients with Duchenne muscular
The European Medicines Agency (EMA) has started a review of two Novo Nordisk drugs used to treat obesity and those overweight, following reports of suicidal thoughts or se
The EMA has launched a consultation on the circumstances in which single-arm trials (SATs) – those without a control group – can be used to support marketing applications
The Novo Nordisk Foundation, the Bill & Melinda Gates Foundation, and Wellcome have joined forces to tackle some of the most pressing threats to human health and wellb
It’s 2024, and in most clinical trials, data is still being moved from the EHR to the EDC manually – with employees reading data from one screen and typing it onto another.