The rapid evolution of AI Healthcare Policy is evident in the Health & AI Policy Index (HAPI) snapshot from January 1, 2026, which catalogs 240 policies illustrating swift expansion of artificial intelligence governance across U...

The U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection as the first treatment for chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This Hepcludex HDV approval addresses a previously unmet need for patients faci...

The CHMP recommendations 2026 from the 18–21 May meeting delivered eight positive opinions for new medicines, thirteen extensions of therapeutic indications, and one negative opinion. These decisions bring meaningful progress in areas with significant unmet need, most notably idiopathic pulmonary...

Clinical trial monitoring shows that in the first quarter of 2026, an average of 208 new clinical trial applications were submitted monthly through the Clinical Trials Information System, yielding 668 total submissions of which 538 received authorisation. The median time from submission to decisi...

Novartis oncology advancements take center stage as the company prepares to unveil findings from more than 65 abstracts at the upcoming ASCO and EHA meetings. These presentations spotlight progress with Pluvicto, Kisqali, and Scemblix while reinforcing the firm’s commitment to transforming outcom...

The EUDAMED Implementation 2026 will require mandatory use of four key modules in the European database on medical devices from 28 May 2026. These cover registration of economic operators, device registration via UDI, notified bodies and certificates, plus market surveillance, following earlier v...