Drugs are man-made miracles. They enhance our health, cure diseases, and extend our lives. However, drug development is not easy. It is a remarkably long, expensive, and complex process. On average, ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

Bari Kowal, Senior Vice President, Development Operations & Portfolio Management at Regeneron Clinical trial innovation is a hot topic, but it’s not a new one. The first fully virtual randomized trial ...

The U.S. Food and Drug Administration (FDA) issued this week three guidance documents related to clinical trials: a draft guidance on multiregional trials in oncology, a draft guidance on integrating ...

In today's fast-paced and ever-evolving landscape of clinical trials, the ability to efficiently analyze and visualize data has become paramount. The vast amounts of data generated from these trials ...

On Wednesday, the U.S. Food and Drug Administration (FDA) published three new draft guidances that aim to offer greater clarity to sponsors of cell and gene therapies (CGTs) on issues related to ...

China, already gaining speed in biotechnology, is looking to further accelerate novel drug development by reducing the time regulators take to review clinical trials. In a draft policy posted (Chinese ...

Pasithea Therapeutics Corp. has announced the opening of three clinical trial sites in Romania and Bulgaria for its Phase 1 trial of PAS-004, a macrocyclic MEK inhibitor aimed at treating ...

The clinical trial ecosystem is entering a phase of consolidation and reinvention driven by the collapse of boundaries between functions, data, and even companies themselves.

Clinical development is undergoing a structural shift. Protocols are growing more complex, budgets are shrinking, and expectations from regulators, payers, and patients continue to rise. Meanwhile, ...