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.

The European Union's drug regulator has recommended approval of Moderna's updated formulation of COVID-19 shot Spikevax, the ...

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.

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