FDA

A STAT Examination Lizzy Lawrence

STAT Plus: As controversial decisions mount, FDA shuns public advisory meetings

Matt's Take Matthew Herper

STAT Plus: 5 lessons from Vinay Prasad’s turbulent tenure at the FDA

Politics Lizzy Lawrence

Vinay Prasad, key Makary ally and a focus of controversy at the FDA, is leaving the agency

Adam's Take Adam Feuerstein

STAT Plus: The FDA, urged to avoid controversy, creates a new headache with attack against UniQure

Adam's Biotech Scorecard Adam Feuerstein

STAT Plus: The extremism of the FDA’s Marks and Prasad has come with costs

Biotech Jason Mast

STAT Plus: Prime Medicine to seek approval for gene-editing treatment after two-patient trial

Exclusive Katie Palmer

STAT Plus: FDA grants ‘breakthrough’ status to generative AI chatbot for surgical patients

Biotech Adam Feuerstein

STAT Plus: UniQure plans to seek approval for Huntington’s therapy still blocked by FDA

First Opinion Judy Stecker

I’m a rare disease mom, and I finally have new hope for my son’s future

Politics Lizzy Lawrence and John Wilkerson

STAT Plus: FDA Commissioner Marty Makary defends rare disease drug rejections, Vinay Prasad

Health tech O. Rose Broderick

STAT Plus: Brain implants: What’s standing in the way of pivotal trials, FDA approval

Biotech Jason Mast

STAT Plus: Rare disease advocates fume over FDA’s mixed signals

Exclusive Adam Feuerstein

STAT Plus: A rare disease drug was approvable, then it wasn’t. Inside a surprise rejection by the FDA

Biotech Jason Mast and Lizzy Lawrence

STAT Plus: FDA unveils rules for bespoke gene therapies, predicting flood of rare disease applications 

A STAT Investigation Daniel Payne and Lizzy Lawrence

STAT Plus: Pharma lobbyists focus on a surprising new target: the FDA

Politics Daniel Payne and Lizzy Lawrence

STAT Plus: Lobbying firms with close ties to Trump draw pharma industry clients

Health tech Mario Aguilar and Katie Palmer

STAT Plus: A provocative proposal asks the FDA to let some AI devices on the market without review

Health Sarah Todd

Biohackers and wellness influencers are pushing nicotine as part of their ‘stacks’

Exclusive Lizzy Lawrence

STAT Plus: In first speech to her FDA staff, Høeg says she’ll scrutinize RSV shots and SSRIs in pregnancy

The Readout LOUD Allison DeAngelis, Elaine Chen, and Adam Feuerstein

Hims’ Super Bowl fallout, and the FDA reverses course

Health tech Mario Aguilar and Lizzy Lawrence

STAT Plus: FDA taps AI executive to lead digital health center

D.C. Diagnosis John Wilkerson

STAT Plus: 5 powerful people to know at HHS

Pharmalot Ed Silverman

STAT Plus: New FDA guidance for antibiotic use in food-producing animals prompts criticism over antibiotic resistance

Matt's Take Matthew Herper

STAT Plus: The FDA’s Moderna pirouette is one more sign of chaos at the agency

Politics Lizzy Lawrence and Daniel Payne

STAT Plus: At drugmakers’ forum, Oz gets a friendly embrace, while Makary faces tough questions

First Opinion Parker Crutchfield, Casey Chmura, and Abram Brummett

When IV opioids are in short supply at the hospital, who gets pain relief?

Health Sarah Todd

STAT Plus: Kennedy says he’ll act on legal challenge to ultra-processed foods

Biotech Lizzy Lawrence and Adam Feuerstein

STAT Plus: FDA rejects rare disease therapy from Disc Medicine, early recipient of commissioner’s voucher 

The Readout LOUD Adam Feuerstein, Allison DeAngelis, and Elaine Chen

The FDA’s refusal to review Moderna’s mRNA flu vaccine