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 ...

FDA proposals include ‘major updates’ to simplify biosimilarity studies, reduce unnecessary clinical testing, and ease the ...

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New non-primate draft guidance follows the FDA's wider aim to curtail the use of animal testing in preclinical toxicology.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

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

Judge Pauline Newman has served with distinction on the U.S. Court of Appeals for the Federal Circuit since her appointment ...

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

Researchers from CIIMAR and the University of Helsinki have discovered a new biochemical modification in natural ...