With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are ...

More ‘biosimilar’ medicines should be brought to market in the EU because of a regulatory policy shift on the need to carry out expensive clinical efficacy studies, experts have said.

Veeva Systems VEEV recently introduced SiteVault, a Clinical Trial Management System (CTMS) designed for research sites. It ...

Next Oncology is occupying space in the Texas Medical Center to conduct cancer-fighting clinical trials in Houston.

A key result of a workshop series of European regulatory authorities and HTA agencies: Drug studies should be designed in such a way that they address both regulatory questions and the essential ...

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, ...

Cytonics, an early-stage biopharmaceutical company developing therapies for osteoarthritis, today announced that the last patient has completed their last visit in the Company's first-in-human ...

The HFpEF Summit is a biannual, two-day meeting bringing together internationally recognized leaders in the clinical, biological, and translational study of HFpEF. This summit focused on the latest ...

End-to-end automation could offer significant benefits: speed, accuracy, and scalability. Digital workers perform repetitive ...

Cell and gene therapies offers transformative benefits to patients, including revolutionary treatment potential for cancer, ...

The Lancet research papers build on the WHO’s Guidance for best practices in clinical trials released in September 2024.