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

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 ...

The FDA has released draft guidance on how sponsors can use Bayesian models for clinical trials.

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 ...

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 ...

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

This article summarizes a discussion at LSX Biopharm America on September 11. A panel of industry experts discussed approaches to overcoming the most urgent CMC challenges during the discussion. The ...

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 ...

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 ...

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