A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...

Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...

The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency’s drug program, the ...

While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience ...

The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...

FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and ...

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

MENOPAUSAL THERAPY IN FOCUS — The FDA will hold a panel discussion Thursday on hormone therapy for menopausal women, a pet ...

Despite the Trump administration’s efforts to shrink the FDA, Senate appropriators unanimously advanced a funding bill ...

With a new leadership team and fast-track designation from the US Food and Drug Administration (FDA), clinical-stage oncology ...