US Food and Drug Administration (FDA)

The US Food and Drug Administration granted the therapy Breakthrough Therapy Designation, while the European Medicines Agency awarded it Priority Medicines status.

The Verida system represents a leap forward in CT imaging, incorporating Philips’ third-generation Nano-panel Precise dual-layer detector alongside an AI-driven deep learning reconstruction engine.

When combined with a reduced-calorie diet and regular physical activity, Foundayo helps patients shed excess weight and maintain their progress.

Avlayah’s approval validates Denali’s blood-brain barrier shuttle technology, which the company now applies across five clinical programs targeting Alzheimer’s disease, Parkinson’s disease, and Sanfilippo syndrome type A, among others.

Wegovy HD became the fourth drug to receive FDA approval through the Commissioner’s National Priority Voucher pilot programme.

Psoriasis is a chronic autoimmune disorder in which skin cells multiply excessively, creating thick, itchy, scaly patches that affect more than 8 million Americans.

GlobalData analysis projects that the global nephrology and urology device market, which includes BPH treatments, will reach almost USD12 billion in 2035, up from around USD8.6 billion in 2024.

The decision followed a comprehensive systematic review of published literature, which included case reports containing patient-level data and mechanistic studies that demonstrated the treatment’s potential benefits.

The expansion of Cosentyx to this population addresses a critical gap in care and demonstrates Novartis’ focus on advancing solutions where the company can make the greatest impact on patient outcomes.

The FDA based its approval decision on data from a global Phase IIIb clinical trial demonstrating Arexvy’s effectiveness in the younger adult population.