Rare Disease Day is held on the last day of February to raise awareness for rare diseases and address drug development ...

The FDA has released draft guidance on how sponsors can use Bayesian models for clinical trials.

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 ...

How innovative technologies like AI and gene editing are advancing rare disease drug discovery and development.

Rare disease is a major – and growing – area of clinical research and drug development. Of the FDA’s 46 novel drug approvals ...

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...

In this week’s edition of InnovationRx, we look at cheaper biologic drugs, Novo Nordisk’s $2 billion next-gen obesity drug deal, new ways of fighting cancer, and more.

The potential of using artificial intelligence in drug discovery and development has sparked both excitement and skepticism among scientists, investors, and the general public. Researchers have ...

Medicine stands at a remarkable crossroads. The explosive growth in specialty drug development marks a new golden age of therapeutic innovation. In 1990 there were just 10 specialty drugs on the ...

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 ...

Thanks to modern therapies, a cancer diagnosis is no longer an automatic death sentence. But many patients still suffer from unwanted side effects and limited efficacy. In a recent Bioconjugate ...