July 2025 brought a flicker of hope for people with serious health needs: Congress exempted drugs with multiple orphan indications from the Inflation Reduction Act (IRA)’s Medicare Drug Price ...

Non-animal testing methods could save drugmakers time and money, officials say ...

This analysis is by Bloomberg Intelligence Industry Analyst Andrew Galler and Senior Associate Analyst Jack Maltby. It appeared first on the Bloomberg Terminal. Life sciences is among the most ...

Drug discovery has traditionally been a reductive process—narrowing down, filtering out, and optimizing within established constraints. Generative AI turns that on its head. It is an expansive force, ...

In my previous article, I discussed how AI is rapidly transforming the drug discovery process, significantly accelerating timelines and reducing costs. However, while AI's potential in this domain is ...

Inflation and the Covid-19 pandemic have put pharmaceutical productivity front and center in recent years. Thus, drug companies are under mounting pressure to prove that new treatments are safe and ...

The FDA has released a draft guidance outlining how drug developers can validate new approach methodologies (NAMs) as alternatives to animal testing in preclinical drug developmen ...

FDA’s NAM framework emphasizes context of use, human biological relevance, technical characterization, and fit-for-purpose ...

Organoids, assembloids, and organ-on-a-chip technologies represent transformative advances in the fields of drug discovery, precision medicine, and ...

The U.S. Food and Drug Administration is actively steering drug developers away from traditional animal studies and toward human-biology-based testing methods for monoclonal antibody programs. The ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...