Fda - STAT

Politics By Nicholas Florko

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

First Opinion By Mason Marks

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

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

Politics By Rachel Cohrs

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

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

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

Biotech By Adam Feuerstein

Sarepta wins new drug approval for patients with Duchenne muscular dystrophy, its third marketed treatment

First Opinion By Dorit R. Reiss

Is it time for the FDA to be independent?

Food And Drug Administration Headquarters 2020 fda hearing

First Opinion By Herschel Nachlis

Watch this FDA hearing on Thursday. It’ll help ease your Covid-19 anxieties

D.C. Diagnosis By STAT staff

STAT+ Conversations: The D.C. Diagnosis

Adam's Take By Adam Feuerstein

Do surprise drug rejections signal a more conservative FDA? Don’t bet on it

Adam's Take By Adam Feuerstein

Applied Therapeutics’ muted response to a clinical hold speaks volumes

Adam's Take By Adam Feuerstein

FDA refuses application for HIV drug from CytoDyn, raising more questions about its credibility

Biotech By Adam Feuerstein

Zogenix wins approval for new drug to treat rare type of childhood epilepsy

Adam's Take By Adam Feuerstein

CytoDyn says lead HIV drug was not filed for FDA approval, as previously claimed

Pharma By Adam Feuerstein

Bristol’s MS drug approval is good news for shareholders but patients will have to wait

Pharmalot By Ed Silverman

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All Coverage

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

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

Ellis Unger, an outspoken FDA veteran, retires

Congress presses the FDA to move faster on ALS drugs

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

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

Sarepta wins new drug approval for patients with Duchenne muscular dystrophy, its third marketed treatment

Is it time for the FDA to be independent?

Watch this FDA hearing on Thursday. It’ll help ease your Covid-19 anxieties

STAT+ Conversations: The D.C. Diagnosis

Do surprise drug rejections signal a more conservative FDA? Don’t bet on it

Applied Therapeutics’ muted response to a clinical hold speaks volumes

FDA refuses application for HIV drug from CytoDyn, raising more questions about its credibility

Zogenix wins approval for new drug to treat rare type of childhood epilepsy

CytoDyn says lead HIV drug was not filed for FDA approval, as previously claimed

Bristol’s MS drug approval is good news for shareholders but patients will have to wait

Pharmalittle: Rise in drug costs for large employers slows; experimental TB vaccine proves effective