RFK Jr. has said he does not want to take vaccines away from Americans. But at a closed-door meeting of vaccine scientists in September, a top official at the FDA suggested doing just that. Here's how Vinay Prasad and Tracy Beth Høeg are reshaping vaccine regulation: www.statnews.com/2025/11/12/f...

BREAKING: Longtime cancer regulator Rick Pazdur named director of drug center at FDA www.statnews.com/2025/11/11/f...

NEW from @theresagaff.bsky.social and @chelseacirruzzo.bsky.social: FDA reverses decades-old warning on hormone therapy products for menopause www.statnews.com/2025/11/10/f...

A Sharon Begley byline, almost 5 years after her death. Upon hearing the news James Watson had died, a STAT reporter said in our Slack, "I wish I could read what Sharon would have written." Incredible news: Sharon in fact did pre-write a Watson obit. And it is masterful and excoriating. 🧪🧬🧫

Here is how the search for top drug regulator is going: FDA deputy commissioner Sara Brenner sent an email to CDER staff today soliciting applications to lead the center. More here: www.statnews.com/2025/11/07/f...

NEW: FDA announces six new recipients of priority vouchers, including GLP-1s from Eli Lilly and Novo Nordisk. Most of the recipients have already received some type of FDA approval. www.statnews.com/2025/11/06/f...

Important new analysis from @matthewherper.bsky.social and @lizzylawrence.bsky.social about the ongoing situation at FDA. This quote from an agency staffer sums up the potential concerns. www.statnews.com/2025/11/04/f...

What does all this chaos at FDA mean for biotech and for patients? @matthewherper.bsky.social and I talked to experts, and have more on the drama between the drug and biologics center leaders — "We now have FDA "Mean Girls" burn books out in the open," a source said. www.statnews.com/2025/11/04/f...

Interesting, and perhaps unsurprising given tumult at FDA — FDA Commissioner Marty Makary was supposed to speak at @wsj.com's Future of Health event today. At some point today, he was removed from the agenda.

NEW: Andrew Joseph has the deep dive into the lawsuit filed by biotech investor Kevin Tang against top drug regulator George Tidmarsh, who resigned yesterday. Read more here: www.statnews.com/2025/11/03/g...

To summarize: - The FDA's top drug regulator is out. - He and the FDA's top biologics official are in open warfare. - A lawsuit accuses him of extortion, and he accuses a former associate of the same. Via @lizzylawrence.bsky.social @adamfeuerstein.bsky.social www.statnews.com/2025/11/02/f...

Story has more details now about Tidmarsh's feud with biotech investor Kevin Tang. Tang's company sued Tidmarsh today, accusing him of a "longstanding personal vendetta":

BREAKING: FDA’s top drug regulator George Tidmarsh has been placed on leave after being accused of abusing his regulatory authority - but also after he questioned the commissioner's plan to speed approvals, and clashed with Vinay Prasad. More here: www.statnews.com/2025/11/02/f...

2. Also please read @lizzylawrence.bsky.social's piece on the impact Vinay Prasad is having on #FDA's vaccines division, where between Prasad pushing leaders out and people heading for the exits, there are concerns about #CBER's capacity to function. www.statnews.com/2025/10/31/v...

EXCLUSIVE: A slow-boiling feud between Vinay Prasad and his staff at the FDA is threatening the future of the center that regulates the nation’s vaccines, biological products, and blood supply. Read more here: www.statnews.com/2025/10/31/v...

NEW: FDA moves to ease path for biosimilars as Trump seeks to cut drug costs, via @danielpayne.bsky.social www.statnews.com/2025/10/29/f...

NEW: I talked with the nine companies that won FDA priority review vouchers and asked them how they did it: www.statnews.com/2025/10/24/h...

New reporting now in this updated story — EMD Serono had been discussing IVF with the administration for months, even before Trump was sworn in. Those conversations culminated in a deal this week. But more is on the horizon, including new U.S. investment announcements from the company.

ICYMI: FDA announces first nine recipients of priority drug review vouchers www.statnews.com/2025/10/16/f...

From @adamfeuerstein.bsky.social rstein's excellent panel on FDA & biotech uncertainty yesterday, where Replimune's and Capricor's CEOs talked about their FDA rejections earlier this year: www.statnews.com/2025/10/16/f...

#Breaking: Medicare payments to doctors paused as government shutdown drags on www.statnews.com/2025/10/15/c...

Re-upping our FDA leadership departure tracker, which we updated yesterday. At least 10 top officials have left the agency since June. Feel free to reach out if there are others I have missed. www.statnews.com/2025/04/03/f...

Exclusive: How political pressure is shaping the work of the FDA, from searching for autism treatments to heavily focusing on Covid-19 vaccine adverse events. Read for more details on how the leucovorin decision came about, in particular: www.statnews.com/2025/10/14/f...

NEW: Peter Marks, former top vaccine regulator ousted by RFK Jr. , is joining Eli Lilly. www.statnews.com/2025/10/07/p...

My first post as head of KSJ! Our first public event. This Thursday. Cambridge. Science journalism in a time of crisis. It's going to be 🔥. Join me and @katherinejwu.com @aniloza.bsky.social @sarareardon.bsky.social @akuchment.bsky.social @jeremyfaust.bsky.social and @edenmedina.bsky.social

With last week's announcement on Tylenol, pregnancy & autism — & an FDA panel in July on SSRIs during pregnancy — I've been thinking about exclusion of pregnant women in clinical trials. Talked to some experts about how we got here, and what can change: www.statnews.com/2025/10/02/c...

ICMYI: Unsealed court documents reveal a whistleblower suit over UnitedHealth use of an artery disease test. Also, the maker of the artery disease test was recently bought for $1.3 billion in stock by a bitcoin treasury company backed by Vivek Ramaswamy: www.statnews.com/2025/09/26/u...

#FireproofingTheFDA Panel 3: The Current Crisis at the FDA (1) @lizzylawrence.bsky.social @statnews.com (2) @rachelsachs.bsky.social @washulaw.bsky.social (3) Nathan Cortez SMU Dedman Law (4) Jordan Paradise @loyolachicago.bsky.social Moderator: Avery Emery @sjquinney.bsky.social @utah.edu

Mothers regularly shoulder the "blame" for having a child with autism. So when autistic moms watched Trump insist — despite little scientific evidence — that Tylenol use during pregnancy causes autism, it felt like a return to a dark era. #disability #autism www.statnews.com/2025/09/25/a...

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...