Industry and patient groups largely back CMS’s proposed RAPID pathway but say it should admit diagnostics and devices already ...

The FDA retired the Chief Information Officer title, but Sanjay Sahoo moved to temporarily lead the new Office of Mission ...

Data from the ARC-20 platform study drive optimism for the Phase III program as the company touts favorable efficacy numbers ...

Oncology leaders say they’ve learned how to better design and differentiate newer versions of antibody-drug conjugates ...

A white paper on “Digitally Derived Measures” stresses that the process of incorporating them into clinical trials must start ...

New final guidance on prescription drug use-related software makes clear that without evidence of improved clinical outcomes, labeling must state the software is not necessary for safe and effective ...

The PD-1 blocking immunotherapy is the first approved treatment in a subset of rectal cancer patients, building on one ...

Unlike a recent AI deal last week focused on drug discovery, AstraZeneca’s non-binding agreement with Oracle targets clinical trials, including patient recruitment.

In this week's Digital Health Roundup, BD has struck a $19bn US investment deal for relief from future Section 232 tariffs. UltraSight raises $24m for AI echocardiography, Elixir readies a Japan ...

EMA supports dropping the prescription requirement for Mundipharma’s Nyxoid, but each EU state will decide where it is sold.

The European Commission tells the Pink Sheet that Aumseqa’s unprecedented EU revocation was purely a regulatory ...

The UK wants to change the way medtech companies interact with its medical regulator via a more transparent process and ...