Yesterday’s product development lifecycle relied on documents, estimates, handoffs, and releases paced by meetings. Today a ...

The agency will no longer require studies comparing copycat biologics to their branded counterparts, which could help ...

The challenges of product development may never disappear, but with AI as a core part of the process, I believe the sky is ...

FDA's new guidance streamlines biosimilar development, reducing costs and regulatory hurdles and potentially enhancing market ...

The Fast Company Executive Board is a private, fee-based network of influential leaders, experts, executives, and entrepreneurs who share their insights with our audience. BY Kevin Bailey Artificial ...

Gelteq Limited (“Gelteq” or the “Company”), a clinical and science-based company specialising in gel-based oral delivery ...

By emphasizing analytical studies instead of routine clinical trials, the FDA signals its intent to reduce the cost (often estimated at $100 million to $300 million) and time (typically 6–9 years) ...

With AI shifting the role of software engineers, Google's senior director of product says more developers will be involved in deploying products.