Despite the importance of postmarketing requirements (PMRs) following accelerated approval and well-recognized shortcomings in their rigor and timeliness,

More than 1,000 current and former employees of the US Department of Health and Human Services wrote a letter to Secretary Robert F. Kennedy Jr. on Wednesday, arguing that his leadership has “put the ...

Industry payments to physicians influence prescribing, raising concern for drugs granted accelerated approval that failed confirmatory studies. We measured industry payments for oncology drugs granted...

A STAT Investigation: Inside the research machine that helps UnitedHealth protect its Medicare profits.

A STAT Investigation: Inside the research machine that helps UnitedHealth protect its Medicare profits.

Journal of General Internal Medicine -

Stealth BioTherapeutics, which has been developing a rare disease drug, said it is making contingency plans to close the company after getting "conflicting" signals from the FDA.

Tiffany E Jiang , Reshma Ramachandran , and Joshua J Skydel argue that US requirements for interchangeability are not supported by evidence and hamper use of biosimilars Biological medicines (biologi...

Nearly all of the 10 panelists emphasized what they said were risks of the drugs. Some claimed, without evidence, that antidepressants don't work at all.

Powerful health care companies shape the informational environments around their products. As part of this playbook, companies avoid or thwart the generation and dissemination of accurate information…

FDA Commissioner Marty Makary's vision for the agency risks the best of an agency that mostly has functioned well for the sake of an uncertain payoff.

As surrogate markers are increasingly being accepted by FDA to support approval of new drugs and biologics, it is imperative that patients and clinicians understand whether such novel endpoints are re...

The regulatory approval of new drugs by the Food and Drug Administration (FDA) is a long and complex process and often requires multiple cycles of review, potentially delaying patients’ access to new ...

The FDA today published more than 200 decision letters, known as complete response letters (CRLs).

The FDA's glacial time frame for releasing documents on the Pfizer/BioNTech vaccine is only the latest evidence that the agency needs some major changes.

A federal judge ruled that the swift takedown of health information across several government webpages earlier this year was illegal and vacated agencies’ directives to do so. | January's abrupt removals of public health webpages and datasets to comply with an executive order on gender and sex were a case of "government officials acting first and thinking later," a federal judge wrote in his ruling.