Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.

BioMarin Pharmaceuticals is one of many biotech companies that’s laid off workers over the past two years. Its office in ...

After years of bashing the medical establishment, Drs. Vinay Prasad and Marty Makary are stuck in a trap. Any attempt to ...

A new study from Turkey has raised questions about the potential effects of the Pfizer-BioNTech COVID-19 vaccine on eye health, revealing changes in the cornea’s inner layer that may signal stress or ...

One chemistry tweak made mRNA vaccines dramatically safer and more effective—unlocking new potential for fighting disease.

The US Food and Drug Administration is plowing ahead with sweeping plans to crack down on ultra processed foods and reshape ...

Robert F. Kennedy Jr.’s leadership at Health and Human Services has led to changes in vaccine recommendations and access, ...