FDA Commissioner Dr. Marty Makary explains the agency’s decision to lift the warning on hormone replacement therapy and addresses safety and supply concerns.

Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and ...

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs.

A system that allows drug makers to profit from restricted access will never liberalize on its own—and patients will continue ...

In a NEJM article, Commissioner Martin Makary and top deputy Vinay Prasad argued that the new policy should lower development costs and speed development without compromising agency standards.

Politico has reported that the White House isn’t happy with the FDA’s recent actions surrounding vaccines, fueling public scrutiny of internal decision-making at the regulator. | Politico has reported ...

Drug sponsors should nevertheless bolster their application with “confirmative evidence,” chief regulators Marty Makary and Vinay Prasad said on Wednesday, including mechanistic data or findings from ...

Drugmakers are urging the FDA to reassess the regulatory process of switching medications from prescription to ...

The director of the National Institutes of Health is also taking over as acting head of the Centers for Disease Control and Prevention, according to an administration official.

The agency overrules Vinay Prasad’s refusal to consider Moderna’s shot.