Therapies for rare and deadly disease are dying in Marty Makary’s shop.

The Food and Drug Administration (FDA) is considering placing a black-box warning on antidepressant use in pregnancy, ...

The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.

An unusual about-face that played out at the FDA over the last week illustrated the power of the “Make America Healthy Again” ...

The president overruled his HHS secretary and FDA chief, four people with knowledge of the decision tell POLITICO.

Vinay Prasad is once again head of the FDA’s Center for Biologics Evaluation and Research, after Laura Loomer led a campaign ...

FDA Commissioner Marty Makary said at a press conference Tuesday that scheduling "7-Hydroxymitragynine" (7-OH) kratom extract as an illegal drug will not impact kratom itself, despite trace amounts of ...

FDA Commissioner Dr. Marty Makary joins 'Squawk Box' to discuss his meeting with CEOs of major pharmaceutical and biotech companies, streamlining the drug approval process, the departure of Dr. Vinay ...

The word from the FDA is that Prasad has come back at the request of the regulator's Commissioner, Marty Makary, who ...

The end of the IV saline shortage follows another removal from the FDA’s shortage list in mid-July. Then, the agency removed ...

Vinay Prasad returns as FDA's CBER director after brief exit, raising questions on rare disease drug approvals and mRNA ...

Florida Attorney General James Utheimer filed an emergency rule to classify a concentrated substance commonly found in ...