The US Food and Drug Administration (FDA) is at a crossroads. There is an urgent need to strengthen the integrity of drug approvals and rejections by diffusing the decision-making authority of individ...

This cross-sectional study examines postmarket safety actions for novel oncology drugs that received accelerated Food and Drug Administration (FDA) approval.

Two government officials told STAT that the White House has been involved in final decisions about the FDA's new priority review voucher program for drug companies.

Audio Interview from the New England Journal of Medicine — Interview with Reshma Ramachandran on changes to the FDA’s adverse-event data releases and future directions for enhancing its safety-surveillance infrastructure.

December 20, 2025, Part 1, Volume 159, Number 51, Canada Gazette

Yesterday, #FDA announced its first approval under the Commissioner's National Priority Voucher (#CPNV) pilot – of a new domestic manufacturing line for a 23-year old drug. “The approval,” declared F...

Researchers at The Ohio State University Moritz College of Law and partner universities were recently awarded a grant from Arnold Ventures to support a multi-faceted research project, titled “A Princi...

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 7301 of title 5, United

Merck, Lilly, and Johnson & Johnson are some of the pharma companies who have snagged the many staff leaving the FDA’s oncology positions. The Pink Sheet estimates CDER’s oncology division is operatin...

Working in close collaboration with the Chair in Applied Public Health, the Infectious Disease Innovation Governance (IDIG) Research Fellow will play a leading role in a variety of research and capaci...

It’s reasonable to assess rare-disease drugs differently. That’s why the FDA has been remarkably flexible about these approvals for decades. But some treatments just aren't any good.

Experts raised concerns about the pilot program's larger than expected size and the lack of transparency about the reasons the cohort deserved vouchers over a pool that the FDA said included hundreds ...

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.

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 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.