The US Food and Drug Administration granted the therapy Breakthrough Therapy Designation, while the European Medicines Agency awarded it Priority Medicines status.
MyGenius PRO adds to Bruker’s molecular diagnostics portfolio, which includes InGenius, BeGenius, and LiquidArray assays.
The European Medicines Agency rejected Elevidys for ambulatory patients last year, citing insufficient evidence of effectiveness.
The approval specifically applies to adults diagnosed with obesity and does not extend to individuals who are overweight with a BMI below 30kg/m² using Wegovy for weight management.
Varipulse Pro will receive prominent visibility at the European Heart Rhythm Association (EHRA) annual meeting, where J&J plans to conduct live procedure demonstrations and offer practical training sessions for healthcare professionals.
Since launching in 2024, AI Airlock has grown steadily, moving beyond its initial pilot phase to tackle increasingly complex regulatory questions.
Pamba brings to the role a rich combination of frontline medical experience, executive leadership, and a proven track record of driving healthcare access across Africa.
Beyond the initial payment, Centessa shareholders are set to receive an extra USD9 per share in contingent value rights (CVR), which could increase the total deal value by USD1.5 billion.
Chronic hepatitis B affects an estimated 3.2 million people in Europe alone and more than 250 million people globally.
The UK Health Security Agency (UKHSA) has launched a targeted vaccination programme, beginning with students residing at the University of Kent.