Australian biotech Mesoblast can go ahead with a US filing for its off-the-shelf stem cell therapy for acute graft-versus-host disease (GVHD), after negotiations with the FDA.
The FDA’s commissioner Scott Gottlieb has pledged to crack down on “unscrupulous actors” attempting to treat patients with potentially dangerous or unproven stem cell therapies.
The atrial fibrillation (AFib) detection feature on Apple Watch devices has become the first digital health technology to be qualified under a programme recently introduce
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.