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

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

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 ...

Discover how early CMC, process optimization, and formulation strategy drive scalable, commercially viable drugs.

From the moment we could look up to the skies, humanity has dreamt of what’s up there. And once we got there, how could we master it? And now that we’re there all the time, how can we use it? In 2025, ...

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

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 ...

“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 biotech start-up MindRank has progressed to Phase 3 clinical trials for its ...