FDA Archives

Pharmalot Ed Silverman

FDA scolds Sun Pharma for allegedly backdating documents and fudging records for collecting drug samples

The Readout LOUD Damian Garde, Allison DeAngelis and Adam Feuerstein

Listen: Private equity in autism care, a watershed FDA approval, and the future of ALS treatment

Biotech Adam Feuerstein

Bluebird wins U.S. approval for a gene therapy to treat patients with a rare blood disorder

First Opinion William G. Woods

As a pediatric cancer researcher, I admired the FDA. Then I got ALS

The Readout LOUD Damian Garde, Allison DeAngelis and Adam Feuerstein

Listen: Helen Branswell on monkeypox, plus: an FDA controversy and fake Alzheimer’s data

Politics Matthew Perrone — Associated Press

FDA weighs oversight changes after Juul, formula troubles

Politics Nicholas Florko

The politics of passing a major FDA funding bill just got complicated

Politics Nicholas Florko

Durbin, Collins blast FDA for failure to ban certain synthetic e-cigarettes

Health Nicholas Florko

Court rules Juul can temporarily keep selling e-cigarettes while it prepares challenge to FDA ban

Politics Nicholas Florko

The Biden administration wants to get tough on states’ abortion pill restrictions. It won’t be easy

Health Nicholas Florko

FDA orders Juul e-cigarettes off the market in the U.S.

Politics Nicholas Florko

Despite fanfare, the FDA’s step toward lowering nicotine levels in cigarettes is a very early one

D.C. Diagnosis Lev Facher

The Senate health committee finally marks up its user fee bill

First Opinion Dana Singiser

‘Pink tape’ at the FDA is delaying access to contraception — again

Politics Lev Facher

Key Senate committee proposes a council to ensure FDA better coordinates on accelerated approvals

D.C. Diagnosis Nicholas Florko

A no good, very bad week for the FDA

Politics Nicholas Florko

The FDA says it’s in the dark about thousands of dietary supplement ingredients

D.C. Diagnosis Nicholas Florko

As Congress takes up FDA oversight of dietary supplements, a lobbying showdown looms

Exclusive Nicholas Florko

Senate FDA legislation will include dietary supplement, cosmetic reforms

Politics Nicholas Florko

Congress moves toward reforming FDA accelerated approvals, but with pharma-friendly concessions

D.C. Diagnosis Nicholas Florko

The FDA’s Rob Califf on importing drugs from Canada, on Aduhelm, and on opioids

Politics Nicholas Florko

Medicare’s Brooks-LaSure expects restrictions on accelerated approval drugs, like those for Aduhelm, to be ‘very rare’

Pharma Ed Silverman

The revolving door swings again as Lupin hires an FDA official who oversaw problems at a key plant

D.C. Diagnosis Nicholas Florko

The FDA’s ban on menthol in cigarettes clears a major regulatory hurdle

Politics Nicholas Florko

FDA

Most Read

Brainstorm to seek FDA approval for ALS stem-cell treatment, despite agency objections

A treatment for monkeypox was approved under the FDA’s ‘Animal Rule.’ Here’s what that means

FDA needs to fully review ACAM2000 before allowing its widespread use as a monkeypox vaccine

In a high-profile misstep, the FDA backtracks on its ban on Juul

What we know — and what we may never know — about why the FDA banned Juul

The FDA needs to take another look at laser-based ‘vaginal rejuvenation’

Containing Covid-19 requires rapid tests that are highly sensitive to infections. Why is the FDA asking for something different?

FDA’s kratom ban would harm the public and damage the agency’s credibility

All Coverage

FDA scolds Sun Pharma for allegedly backdating documents and fudging records for collecting drug samples

Listen: Private equity in autism care, a watershed FDA approval, and the future of ALS treatment

Bluebird wins U.S. approval for a gene therapy to treat patients with a rare blood disorder

As a pediatric cancer researcher, I admired the FDA. Then I got ALS

Listen: Helen Branswell on monkeypox, plus: an FDA controversy and fake Alzheimer’s data

FDA weighs oversight changes after Juul, formula troubles

The politics of passing a major FDA funding bill just got complicated

Durbin, Collins blast FDA for failure to ban certain synthetic e-cigarettes

Court rules Juul can temporarily keep selling e-cigarettes while it prepares challenge to FDA ban

The Biden administration wants to get tough on states’ abortion pill restrictions. It won’t be easy

FDA orders Juul e-cigarettes off the market in the U.S.

Despite fanfare, the FDA’s step toward lowering nicotine levels in cigarettes is a very early one

The Senate health committee finally marks up its user fee bill

‘Pink tape’ at the FDA is delaying access to contraception — again

Key Senate committee proposes a council to ensure FDA better coordinates on accelerated approvals

A no good, very bad week for the FDA

The FDA says it’s in the dark about thousands of dietary supplement ingredients

As Congress takes up FDA oversight of dietary supplements, a lobbying showdown looms

Senate FDA legislation will include dietary supplement, cosmetic reforms

Congress moves toward reforming FDA accelerated approvals, but with pharma-friendly concessions

The FDA’s Rob Califf on importing drugs from Canada, on Aduhelm, and on opioids

Medicare’s Brooks-LaSure expects restrictions on accelerated approval drugs, like those for Aduhelm, to be ‘very rare’

The revolving door swings again as Lupin hires an FDA official who oversaw problems at a key plant

The FDA’s ban on menthol in cigarettes clears a major regulatory hurdle

Right to try 2.0: Advocates want to reduce oversight of ‘n of 1’ therapies

You've been selected! STAT+ for less than $2/day

Subscribe to STAT+ for less than $2 per day