Government Agencies

Politics By Nicholas Florko

The FDA has just 3 days to decide how to regulate 6.5 million e-cigarette products. But what if it blows past the deadline?

The Readout LOUD By Damian Garde, Meg Tirrell and Adam Feuerstein

Listen: Elizabeth Holmes on trial, FDA in disarray, & the quest for Covid antivirals

Politics By Rachel Cohrs

Congress demands documents from FDA on controversial approval of Biogen’s Alzheimer’s drug

First Opinion Podcast By Patrick Skerrett

Listen: A father describes the legacy of his son’s ultra-rare disease

Opinions+ By Chris Plance and Nilesh Chandra

Bringing clarity and consistency to CMS’s hospital price transparency rule will be a win for all

By STAT staff

A first-of-its-kind bet for an Alphabet spinout

The Readout LOUD By Damian Garde and Kate Sheridan

Listen: Biden’s drug pricing plan, Wall Street’s Alzheimer’s fixation, & daily 5 a.m. alarms

Politics By Nicholas Florko

Ellis Unger, an outspoken FDA veteran, retires

First Opinion By Keith Flanagan

Congress should fix FDA’s accelerated approval program for the next 30 years

Health Tech By Katie Palmer

‘We don’t unlearn’: What the pandemic has taught regulators about real-world data

Politics By Nicholas Florko

Will controversy over new Alzheimer’s drug spell the end for the FDA’s faster approval process?

Pharmalot By Ed Silverman

As White House mulls FDA commissioner job, a sign of industry backing for Woodcock surfaces

Politics By Lev Facher

Billions in new research funding sparks a lobbying frenzy among patient advocates

Exclusive By Olivia Goldhill

Athira cited altered studies in $15 million NIH grant application, creating legal risk

Pharmalot By Ed Silverman

Federal watchdog will review the controversial FDA approval of Biogen’s Alzheimer’s drug

Pharmalot By Ed Silverman

FDA to importer: keep your active pharma ingredients away from weed killer and antifreeze

First Opinion By Ryan Knox and Cara Tenenbaum

Regulating digital health apps needs user-centered reform

Pharmalot By Ed Silverman

FDA threatens to fine another drug maker for failing to report clinical trial results

Health By Andrew Joseph

CDC recommends masks indoors even for some vaccinated against Covid-19

First Opinion By Gopal Sarma

The first challenge for ARPA-H should be electronic health record migration

Biotech By Nicholas Florko, Damian Garde and Adam Feuerstein

How Biogen found a believer: At the FDA, a hard-nosed regulator was won over on controversial Alzheimer’s drug

Paper cup pills nonadherent noncompliant

Pharmalot By Ed Silverman

FDA plans to study whether pharma reps at conference exhibit booths are telling the truth

Biotech By Joanne Silberner

Accelerated approval, the path used to greenlight Biogen Alzheimer’s drug, has a checkered track record, critics say

Politics By Lev Facher

San Francisco, Austin, or Raleigh? White House contemplates an out-of-D.C. address for new biomedical research agency

Health By Helen Branswell

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A natural pandemic has been terrible. A synthetic one would be even worse

After company protest, FDA agrees to review controversial drug to prevent premature birth

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

A ‘great listening’ to patients could be a powerful legacy of the pandemic

When and how will we know if we need Covid-19 booster shots?

FDA says it will ban all menthol cigarettes and flavored cigars

Scientific, moral imperatives underlie including rare disorders in the ARPA-H mandate

Andrew Cuomo’s Covid-19 nursing home fiasco shows the ethical perils of pandemic policymaking

All Coverage

The FDA has just 3 days to decide how to regulate 6.5 million e-cigarette products. But what if it blows past the deadline?

Listen: Elizabeth Holmes on trial, FDA in disarray, & the quest for Covid antivirals

Congress demands documents from FDA on controversial approval of Biogen’s Alzheimer’s drug

Listen: A father describes the legacy of his son’s ultra-rare disease

Bringing clarity and consistency to CMS’s hospital price transparency rule will be a win for all

A first-of-its-kind bet for an Alphabet spinout

Listen: Biden’s drug pricing plan, Wall Street’s Alzheimer’s fixation, & daily 5 a.m. alarms

Ellis Unger, an outspoken FDA veteran, retires

Congress should fix FDA’s accelerated approval program for the next 30 years

‘We don’t unlearn’: What the pandemic has taught regulators about real-world data

Will controversy over new Alzheimer’s drug spell the end for the FDA’s faster approval process?

As White House mulls FDA commissioner job, a sign of industry backing for Woodcock surfaces

Billions in new research funding sparks a lobbying frenzy among patient advocates

Athira cited altered studies in $15 million NIH grant application, creating legal risk

Federal watchdog will review the controversial FDA approval of Biogen’s Alzheimer’s drug

FDA to importer: keep your active pharma ingredients away from weed killer and antifreeze

Regulating digital health apps needs user-centered reform

FDA threatens to fine another drug maker for failing to report clinical trial results

CDC recommends masks indoors even for some vaccinated against Covid-19

The first challenge for ARPA-H should be electronic health record migration

How Biogen found a believer: At the FDA, a hard-nosed regulator was won over on controversial Alzheimer’s drug

FDA plans to study whether pharma reps at conference exhibit booths are telling the truth

Accelerated approval, the path used to greenlight Biogen Alzheimer’s drug, has a checkered track record, critics say

San Francisco, Austin, or Raleigh? White House contemplates an out-of-D.C. address for new biomedical research agency

Atul Gawande, bureaucrat: A tough job would await the renowned surgeon at USAID

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