The FDA is reportedly considering broadening the types of drugs that can be sold without a prescription, a move some pharmacy experts say could raise safety risks ...

The FDA has announced that a single clinical trial will now be the default requirement for the approval of novel medicines.

FDA truncates drug approval process; Makary pushes for more OTC drugs; Inside the rocky ride for Recursion Pharmaceuticals.

Prasad and Makary disagree that some may believe this move shows the FDA relaxing its standards.

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 ...

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.

Emma Beavin's reporting for this story was supported by a National Ins | The Coalition for Health AI promised the healthcare industry a way to responsibly oversee AI through a nationwide network of AI ...

The results are a pivotal achievement for psychedelic medicines. More than 100m people worldwide struggle with depression that does not respond to conventional treatments, and psychedelics have long ...

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 ...