Very fun to talk about the FDA's crackdown on DTC drug ads on C-SPAN this morning! You can check out the segment here: www.c-span.org/program/wash...

Two tumultuous days. @chelseacirruzzo.bsky.social. @elaineywchen.bsky.social, ans @lizzylawrence.bsky.social report www.statnews.com/2025/09/19/w...

The CDC's vaccine panel recommended that people 6 months and older consult with their doctor before getting the Covid vaccine - preserving insurance coverage of the shots and diverging with the FDA's more limited approval: www.statnews.com/2025/09/19/a...

The CDC is not well, @elizabethcooney.bsky.social writes, based on an account from two of its former leaders at a Senate hearing on Wednesday. www.statnews.com/2025/09/17/m...

Semler Scientific, a device maker that helped UnitedHealth collect billions, settles fraud claims with DOJ — and reports the loss of a "significant" customer www.statnews.com/2025/09/17/s...

NEW: The FDA released about 100 letters yesterday warning companies to take down or alter drug ads the agency found misleading. It's an unprecedented show of force - but after layoffs, does FDA have the resources to fend off potential legal challenges? www.statnews.com/2025/09/17/f...

Great story from @arthurallen202.bsky.social on the FDA moving to abandon advisory committees, which critics say would shield the agency's decisions from public scrutiny: www.statnews.com/2025/09/12/f...

NEW: FDA pledges to crack down on DTC pharma ads www.statnews.com/2025/09/09/t...

STAT is 10! Join us in reflecting on a decade of reporting from the frontiers of health and medicine. We’re proud that since 2015 we’ve delivered urgent, authoritative, and impactful journalism. Celebrate with us: www.statnews.com/stat-10th-an... #STAT10 🧵

FDA commissioner told CNN the agency is launching "intense investigation" into whether Covid shots cause deaths in kids. The shots have been given to billions of people, and researchers have found no evidence of major safety risks aside from myocarditis. www.statnews.com/2025/09/05/f...

NEW: FDA says it will publish reports of adverse events tied to drugs on daily basis www.statnews.com/2025/08/22/f...

Don't miss STAT's analysis of health care CEO's compensation in 2024, led by @bobjherman.bsky.social and @jaspar.bsky.social. 91 health care CEOs earned at least $10 million in 2024. BioNTech CEO Uğur Şahin took home more than $300 million. www.statnews.com/2025/08/18/h...

A look inside the ways UnitedHealth is able to control research into the Medicare Advantage program, from @bobjherman.bsky.social, @caseyross.bsky.social, @tarabannow.bsky.social and me: www.statnews.com/2025/08/11/u...

BREAKING: Vinay Prasad is returning to the FDA to resume his role overseeing vaccine, gene therapy, and blood product regulation — just two weeks after his ouster. www.statnews.com/2025/08/09/v...

Exclusive: In an internal FDA town hall, drug center employees raised concerns about staffing and impromptu expert meetings. Many also got to meet top drug regulator George Tidmarsh for the first time. More here: www.statnews.com/2025/08/08/f...

An examination of Prasad's rise and fall at the FDA: www.statnews.com/2025/07/30/v...

Top drug regulator George Tidmarsh will serve as acting head of biologics after Vinay Prasad's ouster www.statnews.com/2025/07/30/g...

BREAKING: Vinay Prasad is out at FDA www.statnews.com/2025/07/29/v...

The FDA is recommending the DEA crack down on 7-OH, a psychoactive compound derived from the kratom plant. w/ @levfacher.bsky.social: www.statnews.com/2025/07/29/7...

FDA and NIH are moving away from animal testing. Scientists are split on whether that's a good idea, @marissa-russo.bsky.social and I report for @statnews.com after talking with 10+ researchers across academia and biotech. www.statnews.com/2025/07/25/n...

The risks that untreated depression pose to pregnant women often outweigh the risks of taking SSRIs, experts told STAT. A recent FDA panel, featuring mostly antidepressant skeptics, told a different story. More here: www.statnews.com/2025/07/25/s...

The FDA has a new top drug regulator: George Tidmarsh, a former biotech exec. www.statnews.com/2025/07/21/g...

The FDA on Thursday published more than 200 letters that it sent to companies when it rejected their medicines — but only letters that have already been made public, for drugs that were ultimately approved. www.statnews.com/2025/07/10/f...

Exclusive: I spoke with 15 employees at the FDA to get a sense of how the agency is functioning since the April 1 layoffs. They described tanking morale and an intensifying staff exodus. Read more here: www.statnews.com/2025/07/07/f...

#Breaking: The Senate passed a $4.5 trillion tax cut bill after last-minute changes to its health care provisions, as Republicans scrambled to get their party on board. www.statnews.com/2025/07/01/s...

State cancer registries are facing the prospect of funding cuts as CDC decisions near. www.statnews.com/2025/06/26/c...

New video! STAT just published a wild story about a medical device company that went all-in on bitcoin. I spoke with reporters Casey Ross and @lizzylawrence.bsky.social about the whole saga. We also unexpectedly get turned into cartoons by AI! youtu.be/8XYpnnoGTwY @statnews.com

NEW: I obtained a recording of today's FDA drug center town hall. Psychedelics researcher Mike Davis will be deputy drug director. Also, in the wake of the April layoffs, the agency is still figuring out how to build back basic functions. www.statnews.com/2025/06/24/t...

Exclusive: FDA's Makary sought rejection of KalVista’s drug in an unusual move by commissioner, sources say endpoints.news/sources-fda-...

NEW: Why did Semler Scientific, a device company helping insurers like UnitedHealth detect artery disease, start pouring all of its money into Bitcoin? We dug into this question, and why the company to abandoned its mission. More here: www.statnews.com/2025/06/24/s...

Updated this list again. In addition to the top drug regulator Jacqueline Corrigan-Curay and top gene therapy regulator Nicole Verdun, the drug center's top AI policy expert, Tala Fakhouri, is leaving this week. www.statnews.com/2025/04/03/f...

BREAKING: Jacqueline Corrigan-Curay, the top drug regulator at the Food and Drug Administration, is retiring from the agency in July. www.statnews.com/2025/06/23/f...

NEW: Rooting out conflicts of interest on HHS advisory committees is a major priority of RFK Jr and Marty Makary. But the FDA fired folks who screen for COI in April, which may make conflicts less transparent. www.statnews.com/2025/06/23/f...

EXCLUSIVE: The ouster of Nicole Verdun, the FDA's chief regulator of cell and gene therapies, came after disagreements over the review of Capricor's Duchenne therapy. At the same time, some have taken issue with Verdun's management style. Details below: www.statnews.com/2025/06/20/f...

BREAKING: The Supreme Court ruled 6-3 to uphold Tennessee's ban on gender-affirming care for trans minors. Story here, will be updating: www.statnews.com/2025/06/18/s...

BREAKING: Nicole Verdun, top gene therapy regulatory at FDA, has been forced out of the agency www.statnews.com/2025/06/18/t...

NEW: Vinay Prasad will now hold three separate jobs at the Food and Drug Administration, solidifying his position as a top adviser to Commissioner Marty Makary. www.statnews.com/2025/06/18/v...

As @lizzylawrence.bsky.social's article notes, because FDA already has a number of expedited approval programs - including priority review, rolling review, and enhanced meeting schedules - it's not yet clear from the press release what the impact here will be. /1

NEW: The FDA is launching a program to reward companies with accelerated drug review and speedy agency feedback — if their actions align with the agency’s national health priorities. www.statnews.com/2025/06/17/f...

Meet the new members of CDC's vaccine advisory panel, handpicked by RFK Jr.: www.statnews.com/2025/06/11/r...

Helen Chu is one of the ousted #ACIP members. She spoke to me today about her grave concerns for future vaccination policy and vaccine access in the United States. www.statnews.com/2025/06/10/c...

Thank you to @ewscrippsco.bsky.social for honoring our UnitedHealth series with the Excellence in National/International Investigative Reporting Award and the Impact Award! scripps.com/fund/news/sc...

This is the big one: Kennedy is firing the entire #ACIP in a move he says is needed to restore confidence in vaccines. "It scares me to think of what’s ahead,” Mike Osterholm of CIDRAP told me. www.statnews.com/2025/06/09/r...

BREAKING: Health secretary RFK Jr. abruptly fires CDC vaccine advisory panel www.statnews.com/2025/06/09/r...

In a WSJ editorial, RFK Jr removes all ACIP panel members, citing conflicts of interest and the fact that some were lawfully appointed by the Biden Administration. *KENNEDY REMOVING ALL MEMBERS OF CDC PANEL ADVISING ON VACCINES

ICYMI: 4 members of #ACIP, the #CDC 's independent vaccine panel, have been informed they've been terminated, even though they have several years left in their terms. Special government employee status expired & wasn't renewed. Bureaucratic malfunction? Not clear. www.statnews.com/2025/06/08/c...

Delivering #Covid vaccines has never been easy. Secretary Kennedy's unilateral rewriting of the recommendations for kids and pregnant people is going to make things a lot more confusing and challenging. www.statnews.com/2025/06/05/r...

UnitedHealth Group mistakenly sent us confidential talking points that were prepared for the company's shareholder meeting this week. @caseyross.bsky.social, @tarabannow.bsky.social, and I wrote about the document and how executives prepared to assuage investors. www.statnews.com/2025/06/04/u...

#Breaking: 10.9 million people would lose health insurance under Trump’s tax cut bill, CBO projects buff.ly/DnBihzo

mRNA, a Nobel-winning technology harnessed by the Trump admin to create Covid shots, is becoming a political reject as the nation's health leaders openly embrace vaccine skepticism. Inside the political battle over mRNA, from me and @isabellacueto.bsky.social: www.statnews.com/2025/06/02/m...