FDA proposes framework clinical trial designs to guide Bayesian methods, improving efficiency in drug development for rare and pediatric conditions.

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 ...

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.

The pharmaceutical industry is experiencing its own “DeepSeek moment,” according to science writer Hiya Jain. Just as the upstart AI breakthrough caught Silicon Valley off-guard, China is emerging as ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

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 ...

Clinical trials move through four structured phases, from safety testing to long-term effects. Adaptive, basket, and umbrella trials are making cancer research faster and more flexible. Molecular ...

In Darwinian terms, survival isn’t a matter of being the biggest, the fastest, or the strongest of the species, but instead ...

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 ...

One way Takeda lives out its values is by striving to ensure that patients are aware of and can access the company’s clinical ...

A stylized image of Max Barnhart sitting on a chair with his arm on a pillow, receiving an IV infusion. The background is a grid containing a microscope image of malaria parasites flanked on each side ...