Unpredictable FDA and funding woes delay crucial drug approvals, depriving thousands of patients access to vital treatments ...

On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ ...

The U.S. drug regulator said on Friday a unit of Johnson & Johnson issued a correction for certain lots of a part related to ...

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.