Regulatory challenges have been even more top of mind than usual given recent upheaval at the FDA. BioSpace spoke to three industry experts about key issues, which include applying new artificial ...

Oxana Iliach is a Senior Director of Regulatory Strategy at Certara (PA, USA), a biotech company that offers comprehensive solutions for transforming and accelerating drug development. In her spare ...

In the biotechnology sector, artificial intelligence (AI) has emerged as a transformative force with profound implications for drug discovery and development. According to biotech leader Leen Kawas, ...

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 ...

Researchers have applied AI and machine learning to every stage of the drug development process. This includes identifying targets in the body, screening potential candidates, designing drug molecules ...

On Dec 19, 2025, the US Food and Drug Administration (FDA) announced a major milestone by qualifying total hip bone mineral density (BMD), assessed by dual-energy X-ray absorptiometry, as a surrogate ...

Advances in cancer research have led to an increasing number and variety of cancer therapies in the development pipeline, but there are concerns that traditional processes for drug development, ...

Chemists have recently achieved a significant breakthrough by using copper to crack the toughest bond in indole, a complex organic compound. This advancement holds immense potential for accelerating ...

Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...

Carlin is a vice president at Pathway Policy Group and a veterinarian. Paragas is the CEO and founder of DVLP Medicines and a virologist. The Food and Drug Administration’s recent decision to phase ...