FDA Archives

Health Tech Mario Aguilar

Top FDA official acknowledges agency’s slow process for reviewing health app updates

Exclusive Rachel Cohrs

Democrats concede to clean user fee agreement to fund FDA

Pharmalot Ed Silverman

Catalent is scolded by FDA for quality control issues at a plant that helps make Covid-19 vaccines

Politics Nicholas Florko

Coors, Mondelez, and other big food companies want to sell CBD-filled food and drinks. The FDA is staunchly opposed

The Readout LOUD Damian Garde, Allison DeAngelis and Adam Feuerstein

Illumina’s $8 billion limbo, a new treatment for ALS, & Emirati biotech funding

First Opinion Podcast Patrick Skerrett

Listen: A doctor with ALS laments the slow pace for drug approval

First Opinion Michael B. Farber and Anand Shah

The FDA is at a crossroads for reducing tobacco-related disease and death

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

First Opinion William G. Woods

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

Biotech Adam Feuerstein

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

Health Andrew Joseph

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

First Opinion Caitlin Rivers and Tom Inglesby

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

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

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

Politics Nicholas Florko

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

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

FDA

Most Read

Patients for Affordable Drugs taps new leader

FDA and USDA need to get on board with the CDC about reducing antibiotic use in raising animals for food

FDA funding negotiations heat up ahead of September deadline

In reversal, FDA advisers vote to support approval of Amylyx’s drug for ALS

FDA authorizes Pfizer and Moderna Covid boosters targeted against Omicron strains

The FDA stands by as the vaping industry flouts its orders

Pfizer seeks authorization for updated Covid vaccine, without fresh clinical trial data

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

All Coverage

Top FDA official acknowledges agency’s slow process for reviewing health app updates

Democrats concede to clean user fee agreement to fund FDA

Catalent is scolded by FDA for quality control issues at a plant that helps make Covid-19 vaccines

Coors, Mondelez, and other big food companies want to sell CBD-filled food and drinks. The FDA is staunchly opposed

Illumina’s $8 billion limbo, a new treatment for ALS, & Emirati biotech funding

Listen: A doctor with ALS laments the slow pace for drug approval

The FDA is at a crossroads for reducing tobacco-related disease and death

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

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

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

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

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

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

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