FDA

Politics Lizzy Lawrence

STAT Plus: FDA finalizes plan to regulate some lab-developed tests

Health Helen Branswell

There’s never a good time to drink raw milk. But now’s a really bad time as bird flu infects cows

Politics Sarah Owermohle

STAT Plus: Biden administration punts menthol cigarette rule indefinitely

Health Helen Branswell, Nicholas Florko, Megan Molteni, and Rachel Cohrs Zhang

H5N1 bird flu virus particles found in pasteurized milk but FDA says commercial milk supply appears safe

Biotech Jason Mast

STAT Plus: Day One drug for common childhood brain tumor approved by FDA

First Opinion Peter J. Pitts and Timothy R. Franson

Bashing accelerated approval isn’t supported by the data

Opinions+ Lee A. Fleisher and Matthew A. Fleisher

STAT Plus: Use evidence to support early coverage of gene therapy after accelerated approval

First Opinion Jennifer Handt

An FDA pathway can accelerate innovation for Duchenne muscular dystrophy

Opinions+ Wendy Cheng

STAT Plus: How AI can help satisfy FDA’s drug, device diversity requirements

Politics Nicholas Florko

STAT Plus: Grocers are pushing legislation they claim would enhance food safety. Advocates say it would gut FDA rules

Health tech Associated Press

STAT Plus: Philips, maker of millions of defective sleep apnea machines, ordered to overhaul manufacturing

Health tech Lizzy Lawrence and Matthew Herper

STAT Plus: Device made by company J&J is buying for $13 billion clears hurdle in independent study

Health Jonathan Wosen

STAT Plus: About half of cancer drugs given accelerated approval don’t show improved survival or quality of life

Health tech Megan Molteni

STAT Plus: DNA test that predicts opioid addiction should be pulled off the market, critics urge the FDA

Health tech Lizzy Lawrence

STAT Plus: FDA approves TriClip for tricuspid heart valve disease, pitting Abbott against Edwards

The Readout Meghana Keshavan

STAT Plus: Lawmakers want to add more Chinese biotechs to defense list

Health tech Lizzy Lawrence

STAT Plus: FDA clears digital stethoscope company’s AI algorithm for heart failure

Health tech Lizzy Lawrence

STAT Plus: This AI company scans penis pictures for STIs. Its unproven tech is in an FDA gray zone

Health tech Mario Aguilar

STAT Plus: Otsuka’s digital treatment for depression cleared by FDA, as pharma tries to crack tricky market

The Readout Meghana Keshavan

STAT Plus: Aardvark Therapeutics gearing up for $200 million IPO

The Readout Damian Garde

STAT Plus: What’s Congress going to do with WuXi?

Politics Sarah Owermohle

STAT Plus: Who can sue the FDA? Answering Justice Alito’s question from the mifepristone arguments

Politics Nicholas Florko

STAT Plus: Does decaf coffee contain a harmful additive? Advocates want to ban a certain chemical in the brew

The Readout Damian Garde

STAT Plus: Brazil’s plan for low-cost CAR-Ts

Pharmalot Ed Silverman

STAT Plus: FDA is still struggling to inspect clinical research sites, watchdog finds

Politics Sarah Owermohle

STAT Plus: Supreme Court mifepristone arguments focus on physicians’ right to sue, not FDA judgment

The Readout Meghana Keshavan

How will the Supreme Court’s mifepristone decision impact biopharma?

Politics Sarah Owermohle

STAT Plus: SCOTUS’ abortion pill mifepristone case is really about the FDA

Biotech Jason Mast

STAT Plus: Patient advocates clash over wisdom of ‘approving drugs faster and faster’