At POC, an informed prescription requires more than reading the indication and dosing section of a drug label,” says ...

In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency could maintain its pace in reviewing new drug applications. By the end of the ...

FDA’s focus on playing a direct role in lowering drug prices may provide opportunities for some pharmaceutical companies to seek a regulatory advantage. But it also places enormous pressure on ...

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...

A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved under the U.S. Food and Drug Administration's "Breakthrough Therapy ...

The US Food and Drug Administration (FDA) on Wednesday sought comments on a new effort to provide more clarity on the agency’s pharmaceutical application review and decision-making process. FDA ...

Uncertainties about the benefits and harms of new drugs are common at the time of drugs’ approval. It is unclear to what extent the Food and Drug Administration (FDA) communicates these uncertainties ...

OTTAWA--Canada said Friday it intends to accelerate drug approvals in the country by relying on work done by foreign pharmaceutical regulators. Canada's health department said in a notice that this ...

Illustration of New Drug Application paperwork surrounded by pills, vials, and DNA. The US Food and Drug Administration approved 46 new molecular entities in 2025. Credit: C&EN/Shutterstock The year ...