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FDA

Adam's Take Adam Feuerstein

STAT Plus: Amylyx’s ALS drug launch starts strong. That could be trouble for the FDA

The FDA could face a quandary if an ongoing and larger clinical trial shows ALS patients aren’t benefiting from the drug.

Biotech Adam Feuerstein

STAT Plus: FDA approves first treatment for Rett syndrome, a genetic neurological disease

Health Tech Ben Brody

STAT Plus: ‘Truth is losing the battle’: FDA commissioner on grappling with a wave of health misinformation

Health Brittany Trang

FDA issues rare comment on approval of Covid and flu home test from company that went bankrupt

Politics Lev Facher

STAT Plus: Becerra: Judge set to rule on abortion pill is ‘beginning to read the law’

All Coverage

The Readout LOUD Damian Garde, Meg Tirrell and Adam Feuerstein

Listen: Robert Califf on how drugs get approved, plus the nascent revolution in obesity

Politics John Wilkerson

STAT Plus: Biden makes drug pricing a central part of his deficit reduction plans

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Pharmalot Ed Silverman

STAT Plus: Controversial drug for premature birth is withdrawn by manufacturer after battle with FDA

Politics Andrew Joseph

STAT Plus: Q&A: Califf on obesity drugs, advisory panels, and how threats hurt recruitment at FDA

Health Jonathan Saltzman — Boston Globe

STAT Plus: Foundation charges cancer patients $83,000 for unproven but promising experimental drug

Pharmalot Ed Silverman

STAT Plus: FDA cites Cipla for placing important manufacturing records in the trash

The Readout LOUD Damian Garde, Meg Tirrell and Adam Feuerstein

Listen: The next CRISPR fight, cheaper insulin, & an FDA shuffle

Pharmalot Ed Silverman

STAT Plus: Pharmalittle: Eli Lilly cuts prices for some insulin products; congressional committee opens probe into PBMs

Biotech Adam Feuerstein

STAT Plus: FDA approves Reata’s treatment for rare neurological disease

Biotech Adam Feuerstein and John Wilkerson

STAT Plus: New head of FDA’s neuroscience office takes over at crucial time

First Opinion Judy Stecker

My son’s time is running out due to a rare disease. The FDA needs to add more clinical trial flexibility

Pharmalot Damian Garde

STAT Plus: Pharmalittle: India sends two pharma execs to prison; FDA’s neurology boss departs

Pharmalot Ed Silverman

STAT Plus: FDA is petitioned to boost enforcement of trial sponsors that fail to register studies or report results

Biotech Adam Feuerstein and Damian Garde

STAT Plus: FDA’s Billy Dunn, key figure in approval of Aduhelm, to leave agency

Adam's Take Adam Feuerstein

STAT Plus: For Cytokinetics, an FDA rejection of its heart drug would help, not hinder

Health Brittany Trang

The FDA has cleared the first home flu and Covid test — but its maker just declared bankruptcy

Health Nicholas Florko

STAT Plus: FDA’s top tobacco regulator is ready to talk about the benefits of e-cigs versus cigarettes

Pharmalot Ed Silverman

STAT Plus: A dozen states sue the FDA in hopes of easing abortion pill restrictions

Politics Sarah Owermohle

STAT Plus: VP Harris: Abortion pill case could take ‘constitutional right’ from Americans

Health Tech Lizzy Lawrence

STAT Plus: AI developers battle with FDA, what’s next with Amazon and One Medical, & protecting wearables data

First Opinion Paul J. Hastings

The Supreme Court doesn’t belong in your medicine cabinet

Pharma Eric Boodman

‘A slippery slope’: A looming nationwide abortion pill ban could undermine the entire drug approval system

Health Tech Lizzy Lawrence

STAT Plus: The FDA plans to regulate far more AI tools as devices. The industry won’t go down without a fight

Health Nicholas Florko

FDA fines four companies for selling unapproved vapes