Fda - STAT

Politics By Lev Facher

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

Biotech By Damian Garde, Adam Feuerstein, Matthew Herper, and Nicholas Florko

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

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 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

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

Health By Andrew Joseph

New Vertex cystic fibrosis drug approved, extending treatments to 90% of patients

Pharmalot By Ed Silverman

FDA bid to bolster generic competition and combat shortages isn’t working — yet

Pharmalot By Ed Silverman

Pharmalittle: Judge orders pause in suits against Purdue and Sacklers; Teva must face opioid trial

First Opinion By Michael Cohen-Wolkowiez and Kanecia Zimmerman

FDA’s research guidance will help take guesswork out of drug dosing in newborns

Pharmalot By Ed Silverman

Most Read

FDA to require strong warnings about combining pain pills with anxiety medication

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

CRISPR gene editing fervor pushes another biotech to go public

The untold story of TV’s first prescription drug ad

Newer $285 painkiller no better than older $3 treatment, studies say

A controversial stimulant is found in many easy-to-buy supplements

Major trial casts doubt on leading device to heal bone fractures

All Coverage

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

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

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

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

New Vertex cystic fibrosis drug approved, extending treatments to 90% of patients

FDA bid to bolster generic competition and combat shortages isn’t working — yet

Pharmalittle: Judge orders pause in suits against Purdue and Sacklers; Teva must face opioid trial

FDA’s research guidance will help take guesswork out of drug dosing in newborns

Pharmalittle: Mallinckrodt mulls restructuring as opioid trial nears; the next FDA commissioner will be …