Early-stage regulatory strategy is becoming a powerful driver of speed, risk reduction, and commercial value in drug ...

Government regulations affect drug development, often prolonging the process, but they ensure safety and efficacy to protect ...

Thermo Fisher Scientific is acquiring Clario for roughly $8.9 billion, a major move to boost its clinical research services.

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

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 ...

Explore how patient experience data shapes regulatory drug decisions, enhancing the patient-focused drug development initiative for better treatment outcomes. Patient experience data are critical to ...

Drugs have been tested on animals for over a century, but new technology may one day eliminate the need to do so. Congress and the FDA are pushing pharmaceutical companies to replace animals with ...

“There are over 600,000 drugs in the Korea Chemical Bank alone. It felt overwhelming to find a drug that perfectly fits the protein structure we’re targeting among them. That’s when I thought of AI ...

The company was aiming for approval in the second half of 2028, paving the way for a market launch in 2029 Hangzhou-based ...

Lucy Xiaolu Wang does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond ...