Jason Mast

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Brain implants: What's standing in the way of pivotal trials, FDA approval Thirty years after scientists demonstrated how brain implants can help rhesus monkeys move robotic limbs using only their mind, the clinical pathway for the technology is still a little out of focus.

Brain-computer implants have helped some patients with ALS or paralysis move, speak and function

So why are they not yet approved? Companies, researchers and regulators can't agree on how to actually prove, in large trials, they work

Via @rosebroderick.bsky.social
www.statnews.com/2026/02/26/b...

Lonny Fritzler installs paneling on a future therapeutic foster home for kids whose parents need addiction treatment elsewhere. He says he had to leave his hometown of Lodge Grass to recover from his own addiction to meth.

Illustration by Oona Zenda of a man having to weigh prioritizing either his job or access to health care with a lawmaker in the background.

Hundreds of people join a protest in downtown Hamilton, Montana, in April supporting the work of federal employees as President Donald Trump oversees efforts to restructure the nation’s government.

Hi — new to BlueSky! I’m a journalist covering how health policy and systems impact people. Lately I’ve reported on federal cuts hitting a rural bioscience hub, a town recovering from meth, and a man who said he had to break Medicaid rules.

Based in Montana, I write for both 📰 and 📻

Pharma lobbyists focus on a surprising new target: the FDA Lobbyists told STAT they believe the odds of approval go up if a decision can be spun as a win for the Trump administration.

“It was always the case: if it’s FDA, leave it alone,” one lobbyist told STAT. “There’s been a swing. … Now the conversations are: Can we influence the process? I had never had that conversation before.”

STAT wins fourth Polk Award for reporting on impact of Trump on health STAT has won its fourth Polk Award in five years for documenting the Trump administration’s shakeup of the FDA, scientific research, and public health.

Huge congrats to @lizzylawrence.bsky.social for winning a George Polk award for her unrelenting coverage of turmoil at the FDA over the past year. The STAT team was also recognized for our reporting on the Trump admin's impact on health and science.

www.statnews.com/2026/02/18/s...

FDA reverses course, agrees to review Moderna’s flu vaccine The FDA reversed course and told Moderna it would review its application for a new flu vaccine, the company announced Wednesday.

BREAKING: FDA reverses course and will now review Moderna's flu vaccine, the company announced Wednesday www.statnews.com/2026/02/18/f...

Vertex’s CRISPR treatment for sickle cell disease hits unexpected roadblock Vertex is running out of time to establish Casgevy as a transformative treatment for sickle cell.

Vertex’s $VRTX CRISPR cure for sickle cell has been slow to launch, reaching just 60 patients in 2 years.

Doctors told STAT there's been a surprising culprit: They often can't collect enough cells to make the therapy

www.statnews.com/2026/02/05/v...

Why Bristol Myers Squibb believes a decades-old drug can treat Alzheimer’s Why Bristol Myers Squibb is banking on a decades-old drug to help secure its future.

Why Bristol Myers Squibb believes a decades-old drug can treat Alzheimer’s

www.statnews.com/2026/02/02/b...

Recently out from pedi oncology colleagues, about "cancer exceptionalism."

tl;dr: We accept therapy-induced malignancies as part of the benefit-risk calculus when treating cancer, but are unwilling to weigh them in the balance when treating nonmalignant disease. pmc.ncbi.nlm.nih.gov/articles/PMC...

FDA halts gene therapy trials after brain tumor found in patient FDA paused trials for two experimental gene therapies from Regenxbio after one child developed a brain tumor.

FDA halts two Regenxbio gene therapy programs after brain tumor found in patient

Patient is asymptomatic. FDA was supposed to make a decision on lead program, for Hunter syndrome, on February 8

www.statnews.com/2026/01/28/f...

FDA’s new ‘plausible mechanism pathway’ for personalized gene editing raises concerns A new FDA pathway meant to enable one-time gene-editing cures could, ethicists warn, become a Pandora's box.

Scholars raise concerns about new FDA pathway for personalized CRISPR treatments

'When the FDA opens the door to these things, there’s a lot of pressure to then open the door a little wider and a little wider until an exceptional program becomes the norm'

www.statnews.com/2026/01/26/f...

FDA’s new ‘plausible mechanism pathway’ for personalized gene editing raises concerns A new FDA pathway meant to enable one-time gene-editing cures could, ethicists warn, become a Pandora's box.

Big oops
www.statnews.com/2026/01/26/f...

Endometriosis often takes years to diagnose. Startups want to change that At least a dozen biotech companies are developing tools to diagnose endometriosis more easily.

Endometriosis often takes years to diagnose. Startups want to change that

Scientists hunt for biomarkers in blood, menstrual fluid, spit, and stool

www.statnews.com/2026/01/26/e...

FDA’s new ‘plausible mechanism pathway’ for personalized gene editing raises concerns A new FDA pathway meant to enable one-time gene-editing cures could, ethicists warn, become a Pandora's box.

Thanks to @jasonmast.bsky.social for highlighting our analysis of FDA's new plausible mechanism pathway in @statnews.com.

Key pts:
- Plausible mech is a great idea for n of 1/few
- FDA needs to stop advancing policy via journal article
- Impt open Qs on scope

www.statnews.com/2026/01/26/f...

Scholars raise concerns about new FDA pathway for personalized CRISPR treatments

'When the FDA opens the door to these things, there’s a lot of pressure to then open the door a little wider and a little wider until an exceptional program becomes the norm'

DHS has shot 12 people during immigration enforcement operations since September:

Federal health officials slash recommended childhood vaccinations under Trump’s directive The number of recommended childhood shots drops from 17 to 11.

Federal health officials slash recommended childhood vaccinations under Trump’s directive www.statnews.com/2026/01/05/c...

American Science, Shattered An eight-decade partnership between universities and the federal government made U.S. science preeminent. It took Trump less than a year to shred that

All ten parts of our series attempting to put our arms around the ramifications of various cuts and disruptions to the scientific enterprise this year are live, and you can read them here:

www.statnews.com/american-sci...

3 key issues to watch at FDA as Makary struggles to stabilize the agency 3 key issues to watch at FDA as Makary struggles to stabilize the agency

Welcome back to the @statnews.com “3 To Watch” series where instead of closing the year with a review of the past, we focus on what's ahead. First up: 3 key issues to watch at FDA as Makary struggles to stabilize the agency. Vaccine policy is #2 💉via @lizzylawrence.bsky.social

Fighting for Breath: The FDA’s Lax Generic Drug Rules Put Her Life at Risk Lung transplant patient Hannah Goetz’s life depended on the generic version of the critical drug tacrolimus. It was supposed to be equivalent to the brand-name medication — but the FDA doesn’t always ...

NEW: How the FDA’s Lax Generic Drug Rules Put Her Life at Risk

CDC awards grant to controversial Danish researchers with ties to top FDA official CDC awards grant to controversial Danish researchers with ties to top FDA official Tracy Beth Høeg.

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:

Article about scientists leaving (or not leaving) the US - including me!
I landed in a truly great spot - but what's happening in the US is messed up.
@isemevol.bsky.social @sfstatebio.bsky.social @umontpellier.bsky.social

Amid talk of a brain drain, some scientists leave U.S. behind “A large part of what we loved about the United States is no longer there”: Amid talk of a brain drain, some scientists leave the U.S. behind.

Amid talk of a brain drain, some scientists leave U.S. behind www.statnews.com/2025/12/17/r...

Data on Humana’s clinics looked dismal. Then its corporate research machine got to work STAT investigation: Internal documents show how Humana is reshaping the debate over Medicare Advantage.

A @statnews.com investigation reveals Humana is skewing the debate over how to care for older Americans.

www.statnews.com/2025/12/16/i...

Child’s sudden death unnerves a promising area of gene therapy research Researchers hoped they had finally found a way to get gene therapies past the blood-brain barrier. Then the first patient died.

A child’s sudden death unnerves a promising area of gene therapy research

www.statnews.com/2025/12/15/g...

Early-career trans researchers reconsider their futures amid lost funding and fear The chaos created by the freezing and termination of billions of dollars of research grants has left trans academics especially vulnerable.

Early-career trans researchers reconsider their futures amid lost funding and fear

Part 6 in STAT's American Science, Shattered series, looking at what the Trump Administration has done to science and health in 11 months
www.statnews.com/2025/12/09/h...

Dyne Therapeutics plans to file for approval for next-generation Duchenne drug Dyne Therapeutics plans to submit its next-gen Duchenne muscular dystrophy drug to the FDA after a successful trial.

Dyne $DYN plans to file for approval for next-generation Duchenne drug

Infusion could be a more effective version of controversial Sarepta drug Exondys

www.statnews.com/2025/12/08/d...

Trump has ‘shaken the hell’ out of the 80-year research pact between the government and universities. What now? Trump has "shaken the hell" out of the 80-year research pact between the government and universities. What now?

"Trump has ‘shaken the hell’ out of the 80-year research pact between the government and universities. What now?"

The first in a remarkable series looking at what the Trump Administration has done to American science and health over 11 months

www.statnews.com/2025/12/04/a...

Top drug regulator Richard Pazdur set to leave FDA Top drug regulator Richard Pazdur filed papers to retire from the Food and Drug Administration at the end of this month, but could withdraw them.

Top drug regulator Richard Pazdur set to leave FDA www.statnews.com/2025/12/02/r... via @statnews.com