New draft guidance from the FDA is urging pharma companies to accelerate efforts to transition from animal testing to non-animal alternatives.

Lawmakers on a bipartisan House panel conveyed they are ready to tackle China’s growing dominance in the development of new medicines and the ingredients that

AstraZeneca, Sanofi, AbbVie and Novartis will again face claims that they charged “unlawfully inflated prices” under the 340B drug discount program, after the case was

The FDA will now consider granting its regenerative medicine designations to experimental therapies even if they are on clinical hold, a shift in operating procedures

The FDA unveiled long-awaited draft guidance on how biopharma companies can validate new approaches for toxicology and other early-phase safety studies, potentially reducing the animal