FDA

FDA news roundup. Food and Drug Administration stories include proposed changes to nutrition fact labels, the safety of the pharmaceutical supply chain, regulating high blood pressure devices, and a fact check on Vivek Ramaswamy’s call to gut the FDA.

Other stories include FDA approval of Pfizer’s RSV vaccine, an approved treatment for a rare bone disease, and a warning over misleading promotional materials for a COPD drug.

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FDA calls for treatments for meth and cocaine addiction

Food and Drug Administration seeks to spur drug manufacturers to develop treatments for addiction to meth, cocaine, or prescription stimulants.

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Health Tech Lizzy Lawrence

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FDA calls for treatments for meth and cocaine addiction

Markey and Manchin urge FDA to stop its study of opioids for chronic pain

STAT Plus: FDA cites Fresenius Kabi for contamination problems that CDC linked to deadly sepsis cases

STAT Plus: How payer-participating trials could help transform clinical research on FDA-approved drugs

The FDA needs to take another look at laser-based ‘vaginal rejuvenation’

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STAT Plus: To prevent amputation in patients with severe vascular disease, a device turns veins into arteries

STAT Plus: The major biotech news updates you need to read today

STAT Plus: Former FDA official lays out how to keep patients safe from risky medical devices

STAT Plus: What we owe ALS patients — and why one company fell short

STAT Plus: FDA seeks to regulate lab-developed tests, closing the ‘Theranos loophole’

Listen: Who discovered GLP-1? Plus: BrainStorm at the FDA and biotech’s slump

STAT Plus: FDA advisers vote overwhelmingly against ALS treatment from BrainStorm

STAT Plus: Over-the-counter Sudafed PE doesn’t work. Neither does our system for evaluating older drugs

STAT Plus: The problem with potential changes to the biosimilar regulatory framework

STAT Plus: BrainStorm’s case for ALS approval relies on ‘grossly deficient’ data, FDA finds

STAT Plus: FDA panel votes against GLP-1 therapy from former diabetes unicorn Intarcia

A thorny ALS debate at the FDA, and the promise of artificial wombs

STAT Plus: Travere kidney drug narrowly fails confirmatory trial following FDA approval

STAT Plus: What to know about the polarizing ALS drug headed for FDA scrutiny

STAT Plus: Approval setback for EpiPen alternative puts spotlight on common anti-competition tactic

STAT Plus: FDA weighs animal data, ethical dilemmas at panel on artificial wombs

STAT Plus: What happened to the House vote on health care price transparency?

STAT Plus: Artificial wombs, after years in development, reach FDA review for human trials

Listen: Covid’s latest surge, Alnylam at the FDA, & the end of an era

STAT Plus: Lawmakers introduce bill to require drugmakers to provide key info to both FDA and U.S. Patent Office

Popular nasal decongestant doesn’t actually relieve congestion, FDA experts say

STAT Plus: Is there a path forward for PEPFAR?

Patients might finally receive practical information with prescriptions — if the FDA doesn’t blow it

STAT Plus: FDA proposes changes to key approval pathway for medical devices, five years after promising

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