FDA Archives

Pharmalot By Ed Silverman

Pharmalittle: Moderna says booster shot raises antibody levels to thwart Omicron; Sanofi buys yet another biotech

Health By Lev Facher

Covid antivirals could be pandemic game-changers. But Americans might struggle to access them

Biotech By Damian Garde

FDA approves first drug for genetic cause of dwarfism

Politics By Nicholas Florko

Could Robert Califf’s ties to tech complicate his FDA nomination?

Biotech By Adam Feuerstein

Biogen, Eisai seek fast approval for second Alzheimer’s drug, relying on relaxed FDA standard

D.C. Diagnosis By Nicholas Florko

Scott Gottlieb: Trump’s shadow FDA commissioner during Covid-19?

Biotech By Adam Feuerstein

Facing pressure from ALS patients and advocates, the FDA does about-face on review of potential treatment

Biotech By Kate Sheridan

FDA dings Kaleido Biosciences for testing a microbiome drug without proper paperwork

Politics By Nicholas Florko and Lev Facher

Two top FDA officials in charge of Covid-19 vaccines to leave agency this fall

Politics By Nicholas Florko

FDA, drug makers propose new pilots aimed at speeding rare disease drugs, as part of user fee update

Politics By Nicholas Florko

Ellis Unger, an outspoken FDA veteran, retires

Politics By Nicholas Florko

Congress presses the FDA to move faster on ALS drugs

D.C. Diagnosis By Nicholas Florko

What happened to the FDA’s toughest regulator?

First Opinion By Scott Brunner

On compounding, the FDA marches to the beat of its own biases

Politics By Rachel Cohrs

Powerful House Democrats demand documents from Biogen about coordination with FDA on new Alzheimer’s drug

Politics By Lev Facher

Experts warn full Covid-19 vaccine approval is no quick fix for hesitancy

Exclusive By Nicholas Florko, Ed Silverman, Rachel Cohrs and Damian Garde

FDA’s expansive Alzheimer’s drug approval surprised even top agency officials

Biotech By Adam Feuerstein

FDA, under fire from critics, revises prescribing information for Biogen’s Alzheimer’s drug

Biotech By Matthew Herper, Damian Garde and Adam Feuerstein

Newly disclosed FDA documents reveal agency’s unprecedented path to approving Aduhelm

Business By Andrew Joseph

Member of FDA’s expert panel resigns over controversial Alzheimer’s therapy approval

Biotech By Adam Feuerstein

Fibrogen admits false heart-safety data for experimental anemia pill shared with FDA, investors

Biotech By Adam Feuerstein

FDA cites lack of evidence in rejecting Acadia Pharma’s bid to expand use of anti-psychosis drug

Adam's Take By Adam Feuerstein

A ‘conditional’ EUA for a CytoDyn Covid treatment? FDA says no such thing exists

Biotech By Adam Feuerstein

Is a leaderless FDA clamping down on drug reviews? Not knowing is weighing heavy on biotech

Biotech By Adam Feuerstein

Most Read

Democratic senators raise concerns with potential FDA pick

Biogen’s Aduhelm sales fall dramatically below Wall Street’s expectations

Elizabeth Warren on over-the-counter hearing aids, health lobbying, and the FDA’s independence

Is Robert Califf a savvy choice to helm the FDA — again?

In its search for a new FDA commissioner, the White House is relying on insiders for advice

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

FDA calls for federal investigation into its controversial Alzheimer’s drug approval

Despite criticism and concerns, FDA approves a new opioid 10 times more powerful than fentanyl

All Coverage

Pharmalittle: Moderna says booster shot raises antibody levels to thwart Omicron; Sanofi buys yet another biotech

Covid antivirals could be pandemic game-changers. But Americans might struggle to access them

FDA approves first drug for genetic cause of dwarfism

Could Robert Califf’s ties to tech complicate his FDA nomination?

Biogen, Eisai seek fast approval for second Alzheimer’s drug, relying on relaxed FDA standard

Scott Gottlieb: Trump’s shadow FDA commissioner during Covid-19?

Facing pressure from ALS patients and advocates, the FDA does about-face on review of potential treatment

FDA dings Kaleido Biosciences for testing a microbiome drug without proper paperwork

Two top FDA officials in charge of Covid-19 vaccines to leave agency this fall

FDA, drug makers propose new pilots aimed at speeding rare disease drugs, as part of user fee update

Ellis Unger, an outspoken FDA veteran, retires

Congress presses the FDA to move faster on ALS drugs

What happened to the FDA’s toughest regulator?

On compounding, the FDA marches to the beat of its own biases

Powerful House Democrats demand documents from Biogen about coordination with FDA on new Alzheimer’s drug

Experts warn full Covid-19 vaccine approval is no quick fix for hesitancy

FDA’s expansive Alzheimer’s drug approval surprised even top agency officials

FDA, under fire from critics, revises prescribing information for Biogen’s Alzheimer’s drug

Newly disclosed FDA documents reveal agency’s unprecedented path to approving Aduhelm

Member of FDA’s expert panel resigns over controversial Alzheimer’s therapy approval

Fibrogen admits false heart-safety data for experimental anemia pill shared with FDA, investors

FDA cites lack of evidence in rejecting Acadia Pharma’s bid to expand use of anti-psychosis drug

A ‘conditional’ EUA for a CytoDyn Covid treatment? FDA says no such thing exists

Is a leaderless FDA clamping down on drug reviews? Not knowing is weighing heavy on biotech

A surprise FDA advisory panel imperils Fibrogen’s experimental anemia pill