It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...

FDA Commissioner Marty Makary suggests his agency may expedite drug reviews for manufacturers reducing U.S. prices to global ...

Dr. Marty Makary, FDA commissioner, joins 'Squawk Box' to discuss what hindsight tells science about the best route to take post-Covid, changes to the Vaccine Advisory Committee and much more.

Dr. Marty Makary, FDA commissioner, joins 'Squawk Box' to discuss what hindsight tells science about the best route to take ...

“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed ...

Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other ...

By disclosing the CRLs, the FDA provides an insight into common pitfalls that sponsors must rectify to gain approval.

A wave of menopause-related legislation has been introduced across the United States this year, leading to possible shifts in ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

On this week's episode of "The Readout LOUD": a closer look at the NIH’s grant-cutting legal playbook, FDA transparency ...

The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., who has pushed for changes around mRNA ...

Unlike Drs. Adam Cifu and John Mandrola, I do not constantly boast of my "nuance" or claim to be a master of "clinical ...