News

US FDA chief says firings won't hinder agency's target dates for drug reviews
The U.S. Food and Drug Administration will meet its targets for completing reviews of new drugs despite mass firings at the ...
FDA to undo some layoffs, after cuts to inspections and drug safety
Multiple current and laid-off FDA employees said the abrupt layoffs had resulted in delays and disruptions to the agency's ...
FDA delays decision on Stealth BioTherapeutics' rare genetic disorder drug
The U.S. Food and Drug Administration has delayed its decision on marketing approval for Stealth BioTherapeutics' treatment ...
FDA chief says they're looking at whether to approve COVID shots for next winter
The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve COVID-19 vaccines for next winter, citing a lack of data on booster shots.
FDA Chief Says He Won’t Reorganize Agency After Mass Layoffs (1)
The FDA doesn’t plan to execute a reorganization of the agency but will consolidate offices that handle travel, technology, ...
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How Marty Makary’s FDA is embracing a more skeptical view of vaccines
FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.
FDA announces ban for compounded weight loss drugs
Recently, the FDA announced the removal of certain compounded GLP1 ingredients from its drug shortage list. These ingredients ...
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
Novavax said Monday that the Food and Drug Administration was asking the company to run a new clinical trial of its vaccine.
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Amid FDA chaos, approval of a rare disease drug gets delayed — again
Stealth BioTherapeutics had expected the FDA to respond on Tuesday to its marketing application for elamipretide to treat ...
Bread sold in six states recalled over ‘glass fragments’: FDA
The rolls were sold at the retail level in Pennsylvania, California, Connecticut, Maryland, Delaware, and Ohio, according to ...
Wegovy Recalled as FDA Warns Weight Loss Product 'Inappropriately Released'
A batch of the drug is under a limited voluntary recall after a shipping error exposed certain doses to improper temperatures.
FDA says it will phase out petroleum-based food dyes, authorize four natural color additives
The US Food and Drug Administration plans to phase out the use of petroleum-based synthetic dyes in the US food supply due to ...