Patient-centric evidence, such as PROs and RWE, offers insights into patients' needs, enhancing drug development beyond traditional endpoints. Challenges include increased complexity and regulatory ...

In a university lab, an AI system generated millions of novel molecules to fight drug-resistant infections. And they're ...

Rare disease research faces complex regulations, small patient populations, and high costs. As traditional incentives wane, ...

New non-primate draft guidance follows the FDA's wider aim to curtail the use of animal testing in preclinical toxicology.

Amaran Biotech, a next-generation Contract Development and Manufacturing Organization (CDMO), announced that its ...

Engineers inspect a line of enormous stainless-steel vats where a biologic drug will soon begin production, derived from cells originating in hamster ovaries. With each vat big enough to make 50,000 ...

The collaboration unites complementary scientific and technical expertise to provide seamless solutions across the ...

The AHA is calling for a framework that balances innovation with appropriate safeguards to protect privacy and patient safety ...

AGC Biologics is partnering with ATUM to integrate technology designed to increase yields and shorten the path to clinical trials.

Syngene has made two significant investments recently — in peptide synthesis and ADC bioconjugation. What do these moves say ...

In this Q&A, John Kirk, principal regulatory specialist at Veristat, explains how the FDA’s Commissioner’s National Priority ...

I haven’t given my diatribe on cheap drugs for a while, but what the hell. It’s a huge deal and no one in a position of power ...