The Physicians Committee for Responsible Medicine applauds the Food and Drug Administration’s newly released draft guidance, ...

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 ...

New non-primate draft guidance follows the agency’s wider aim to curtail the use of animal testing in preclinical toxicology.

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

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

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

Amaran Biotech, a next-generation Contract Development and Manufacturing Organization (CDMO), announced that its self-developed, GMP-grade high-purity vaccine adjuvant AB-801 has received an ...

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 ...

Hank Green talks with us about why research and development make the prescription drug development process long...