This story has now been updated with comments from FDA Commissioner Marty Makary and others:

Scoop: Top FDA official Vinay Prasad overruled the agency’s reviewers when he refused to accept Moderna’s application for a new influenza vaccine, STAT has learned. www.statnews.com/2026/02/11/m...

EXCLUSIVE: Trump administration officials vetoed the FDA's plan to fast-track the review of Compass's psychedelic treatment for severe depression, STAT has learned. The move signals a possible disconnect between senior White House leadership and MAHA. www.statnews.com/2026/02/04/p...

NEW: I obtained a recording of an internal FDA town hall held today, where leaders tried to quell staff and external concerns about the commissioner's voucher program, a controversial new pathway to fast-track certain drugs. Read my exclusive: www.statnews.com/2026/02/03/f...

NEW: You can now access all of STAT's most important FDA reporting from last year in one place. Check out our special report documenting the agency's inner turmoil. reports.statnews.com/products/ins...

You can buy a whole host of sketchy drugs at many gas stations. I wondered why gas stations, of all places, were the premier destination for people seeking quasi-legal recreational (or knockoff pharmaceutical) drugs. I dig into why in this week's @statnews.com STATus Report. youtu.be/4QsVjgIWVZs

Former executives of pain management device company Zynex Medical were indicted on multiple counts of fraud this week www.statnews.com/2026/01/23/f...

Holy shit. HHS says the Africa CDC "is a powerless, fake organization attempting to manufacture credibility by repeating its claims publicly. It is not a reliable source, and its statements should be treated accordingly."

We have the CDC-funded Hepatitis Vaccine trial in Guinea-Bissau protocol. It’s worse than you thought. Check it out, first in Inside Medicine… with @pauloffit.bsky.social David Boulware and others. insidemedicine.substack.com/p/scoop-the-...

NEW: Kennedy added two OB-GYNs to vaccine advisory panel amid review of shots for pregnant women. Their names are Adam Urato and Kimberly Biss. Learn more about them here: www.statnews.com/2026/01/13/n...

Read @elaineywchen.bsky.social's write-up of former top FDA drug regulator Rick Pazdur's explosive panel at STAT's event at #JPM2026 last night, moderated by @matthewherper.bsky.social. Drug makers should be more concerned by what's happening at FDA, Pazdur said. www.statnews.com/2026/01/13/r...

Important reporting from @HelenBranswell and @jaspar: The US is now a global outlier when it comes to vaccine schedules, recommending fewer vaccines than most of its peers. www.statnews.com/2026/01/09/c...

A little scoopy tidbit in STAT's DC Diagnosis newsletter today: Vinay Prasad wants access to FDA employees' calendars, though his own is largely private. He has also instructed employees not to tell their supervisors when he reaches out to schedule meetings.

Nearly half of Trump-appointed experts involved in shaping the new dietary guidelines have financial ties to meat and dairy industries. Exclusive with @sarah-todd.bsky.social and @elizabethcooney.bsky.social --> www.statnews.com/2026/01/07/n...

The FDA is easing regulation for wearable devices and AI-enabled clinical decision support tools. Commissioner Makary intro'd the news at #CES2026, telling attendees the FDA will "get out of the way" and "promote AI." Read our news analysis: www.statnews.com/2026/01/06/f...

The Trump administration has dramatically slashed the childhood vaccine schedule. Medical experts have called the changes "dangerous and unnecessary." Read our analysis of the news and what it means for public health: www.statnews.com/2026/01/05/c...

As we close out the year, wanted to share this running list of FDA leadership departures one last time. Some new names on there include digital health director Jessica Paulsen, and director of clinical policy in the chief medical office Shari Targum. www.statnews.com/2025/04/03/f...

Here are three key issues to watch at the FDA as Commissioner Makary struggles to stabilize the agency. www.statnews.com/2025/12/22/f...

EXCLUSIVE: The FDA voucher program has become a vehicle for politicization of drug review, staffers say. Staff have been forced to award certain companies vouchers due to White House deals, and at least one voucher was awarded despite staff concerns. www.statnews.com/2025/12/19/f...

W/ @helenbranswell.bsky.social: The CDC has awarded $1.6 million to controversial Danish researchers with ties to top Food and Drug Administration official Tracy Beth Høeg. The funding is for a study on hepatitis B vaccines that some experts say may be unethical. www.statnews.com/2025/12/18/c...

We updated this story with some insights from lawyers and policy experts on whether or not CMS has the legal authority to do this, what challenges to the rules may look like, and when those challenges can happen. Take a read:

Don't miss this investigation from @tarabannow.bsky.social and @caseyross.bsky.social into the way Humana tweaked the presentation of its data to indicate that their corporate business model was the best way to care for older Americans. www.statnews.com/2025/12/16/i...

“The only reason I don’t have this funding is because my last name is Rodriguez.” MOSAIC checked many of the boxes of the administration — but that didn't matter. It was terminated, and left grantees scrambling Next installment of American Science, Shattered: www.statnews.com/2025/12/08/t...

NEW: I dug deep into new top drug regulator Tracy Beth Høeg's record at the FDA so far, talked to agency staff, and even found some old and interesting blog posts, to get a sense of how she'll lead the drug center. TLDR, staff are worried. More here: www.statnews.com/2025/12/11/t...

It was an honor to join this conversation. You can watch below:

🔔 We’re all less informed when journalists’ sources fear retaliation. Tomorrow, join our live webinar with @lizzylawrence.bsky.social, @gracehussain.bsky.social, @fastlerner.bsky.social, Emily Spatz, @harloholm.es and @caitlinvogus.bsky.social. 🕒 2 p.m. EST RSVP: freedom.press/silenced-sou...

W/ Damian Garde on the ground in NYC: Vinay Prasad, FDA’s vaccine regulator, waves off criticism in closed-door remarks www.statnews.com/2025/12/04/v...

ICYMI: @lizzylawrence.bsky.social in @statnews.com News scooped that the @fda.gov is planning to require only a single pivotal clinical trial to be the basis of drug approval, rather than 2 or more.

I know there's a lot of news but if you can tear yourself away from the CDC vaccine committee today — you should really read this series on how the Trump administration has upended science in just 10 months, from my incredibly talented colleagues: www.statnews.com/american-sci...

NEW: FDA will lower the number of clinical trials required for medical product approval from two to one. I obtained a draft of the press release and got to talk to FDA Commissioner Makary about it, and some other things, yesterday: www.statnews.com/2025/12/04/f...

And if you're wondering who Tracy Beth Høeg is, @lizzylawrence.bsky.social already has a profile for you: www.statnews.com/2025/05/19/t...

BREAKING: Tracy Beth Høeg will lead the FDA's drug center. W/ @ChelseaCirruzzo www.statnews.com/2025/12/03/t...

12 former FDA commissioners denounce Vinay Prasad's internal memo on vaccine regulation, from @matthewherper.bsky.social: www.statnews.com/2025/12/03/f...

🔔 Journalists’ sources fear retaliation. We’re all less informed as a result. Join our live webinar with @lizzylawrence.bsky.social, @gracehussain.bsky.social, @fastlerner.bsky.social, Emily Spatz, @harloholm.es and @caitlinvogus.bsky.social. 🗓️ Dec. 9, 2 pm ET RSVP: freedom.press/silenced-sou...

BREAKING: The FDA just removed longtime over-the-counter drug regulator Theresa Michele from her role, just a day after her boss, Rick Pazdur, announced he was retiring. Pazdur had pushed back on efforts from the commissioner to replace career staff. www.statnews.com/2025/12/03/t...

🔔 Journalists’ sources fear retaliation. We’re all less informed as a result. Join our live webinar with @lizzylawrence.bsky.social, @gracehussain.bsky.social, @fastlerner.bsky.social, Emily Spatz, @harloholm.es and @caitlinvogus.bsky.social. 🗓️ Dec. 9, 2 pm ET RSVP: freedom.press/silenced-sou...

STAT's @lizzylawrence.bsky.social had quite a scoop this morning- the FDA's top regulator is retiring after just under a month on the job. @statnews.com www.statnews.com/2025/12/02/r...

RICK PAZDUR is now planning to resign at the end of the year — three weeks after taking the job as FDA's top drug regulator. Big shake-up after a year of turbulence at the agency. Story w @rachelroubein.bsky.social. (And credit to Stat's @lizzylawrence.bsky.social, who beat us out the door.)

BREAKING scoop: Top drug regulator Rick Pazdur filed papers to retire from the FDA at the end of this month, according to agency sources. He alerted leaders at the drug center this morning. He could still withdraw the papers. www.statnews.com/2025/12/02/r...

🧵HHS today announced that Martin Kulldorff has been hired to advise Secretary Kennedy on science policy. Kulldorff is one of many in government who share ties to the Brownstone Institute, a think-tank whose associates seek to limit the government’s role in protecting Americans from disease.

An excellent analysis of the memo Vinay Prasad sent FDA vaccine center employees this weekend, where he called for stricter vax regulation, & said the Covid vax killed kids but did not provide evidence. From @matthewherper.bsky.social & @helenbranswell.bsky.social: www.statnews.com/2025/11/29/c...

Breaking News: Robert F. Kennedy Jr. said he personally instructed the CDC to abandon its position that vaccines do not cause autism. The move underscores his determination to challenge scientific orthodoxy — in this case, that vaccines save lives — and bend the health department to his will.

NEW: FDA review staff was excluded from voting on whether to approve first priority voucher drug. Top leaders like Vinay Prasad, George Tidmarsh, and Tracy Høeg led the vote instead. Read for the full list, and expert reaction from @hollylynchez.bsky.social: www.statnews.com/2025/11/21/t...

Offshift helps truckers build a healthy lifestyle to prevent or manage chronic disease. They can be effective, and yet digital health solutions like those often struggle with like low adoption and engagement, @katiepalmer.bsky.social reports: www.statnews.com/2025/11/18/t... via @statnews.com

A couple excellent stories from my colleagues today. First up, an inside look into how RFK Jr. is managing HHS, from @chelseacirruzzo.bsky.social, @caseyross.bsky.social, and @sarah-todd.bsky.social: www.statnews.com/2025/11/18/r...

ICYMI: @sarah-todd.bsky.social has an excellent analysis of ByHeart's "bizarre" response to an infant botulism outbreak associated with its infant formula www.statnews.com/2025/11/14/b...

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. 🧪🧬🧫