News

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Questions about the FDA’s ‘radical transparency’ efforts
Happy Friday. Today, we talk about the stem cell fire sale at CIRM, and about the FDA’s move to release a limited batch of ...
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FDA rejects Capricor’s DMD cell therapy, asks for more data
The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising ...
FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say
Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...
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NIH grant cuts, FDA transparency questions, and biotech M&A
On this week's episode of "The Readout LOUD": a closer look at the NIH’s grant-cutting legal playbook, FDA transparency ...
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FDA’s AI Rollout Raises Questions Around Readiness, Legality
The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...
FDA vaccine official restricted COVID vaccine approvals against agency advice
A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...
Chocolate Recall Update as FDA Sets Risk Warning
Meijer Inc. announced a recall of thousands of cases of Frederik's Dark Chocolate Almonds on June 13 due to the possible ...
Even low doses of CBD may cause harm to the liver in some people, FDA study finds
An FDA-funded clinical trial found even modest CBD use triggered elevated liver enzymes in some healthy adults, raising ...
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FDA Begins Public Comment Period on Method for Ranking Chemicals in Food for Post-Market Assessments
The U.S. Food and Drug Administration (FDA) announced on June 18, 2025, the release of its proposed method for ranking ...