Policy
Jim O’Neill was deputy secretary at the Department of Health and Human Services and also acting director of the CDC after the abrupt ouster of Susan Monarez in August 2025.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Erika Cheung testified that the data manipulation happened “frequently,” in order to make the company’s lead asset look good to investors.
Amylyx’s decision to submit the NDA, announced Wednesday morning, came on the heels of recent discussions with the FDA, including a pre-NDA meeting held on July 15.
Recently, the National Institutes of Health (NIH)'s removal of genetic data about the COVID-19 virus from its archive was brought into the spotlight.
A patient treated with Astellas Pharma’s experimental gene therapy for patients with X-linked Myotubular Myopathy (XLMTM) has died after a serious adverse event following treatment.
SENS Research Foundation released findings that confirmed the charges of inappropriate behavior raised by two former female employees against Aubrey de Grey.
A recent study suggests that about one-third of cancer indications with Accelerated Approval pathways are still on product labels without follow-up studies confirming their benefits.
September is turning out to be a busy month for the U.S. Food and Drug Administration. Here’s a look at this week’s schedule for PDUFA dates.
President Joe Biden took an aggressive step that mandates vaccination for 100 million Americans who are eligible for preventative medication.
Chin, 57, and Humad, 36, along with the company, were indicted on charges of paying surgeons to use their spinal implants in surgeries.
Elizabeth Holmes heads to court today to face multiple criminal fraud charges that could land the Theranos founder and CEO in prison for more than a decade.