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, ...

A well-connected drug company and Laura Loomer wanted Kennedy ally Vinay Prasad gone. Trump chief of staff Susie Wiles got ...

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

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

The move by Mars marks a step toward appeasing Health and Human Services Secretary Robert F. Kennedy Jr, who has made ...

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

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 ...

Florida’s emergency rule will classify certain concentration forms of 7-hydroxymitragynine opioid products as Schedule 1 controlled substances in Florida, a step FDA recommended for 7-OH opioids in ...