News

In reversal, FDA rehires staff tasked with releasing public records
The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory ...
FDA to rehire fired staffers who booked inspection trips, but other workers remain in limbo
For the second time in recent months, the Food and Drug Administration is bringing back some recently fired employees, ...
Burger Recall Update as FDA Sets Highest Risk Level
A recall of seafood burgers by the Connecticut based company Caraluzzi's Markets has been issued a Class I risk ...
Exclusive-US FDA Asks Some Fired Pharma User Fee Negotiation Staff to Return
Under the current expiring user fee agreements, the FDA commits to complete new drug approval reviews within either 10 months ...
COVID vaccine boosters called into question by FDA chief: ‘Void of data’
Dr. Marty Makary, chief of the FDA, has expressed doubts about the agency approving the COVID-19 vaccine for winter, stating ...
US FDA accepts Novo Nordisk's application for oral Wegovy for weight loss
The U.S. Food and Drug Administration has accepted Novo Nordisk's marketing application for an oral version of its ...
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 ...
AI rules: FDA’s next step
Previous policy allowed up to a 12-month delay before articles were required to be made available to the public for free ...
Novo Nordisk Says FDA Accepted New Drug Application for Wegovy Pill
The Bagsvaerd, Denmark, company said that if the application is approved, Wegovy would become the first oral formulation of a ...
Fierce Pharma3d
FDA puts up placebo testing requirement for new vaccines, potentially hitting COVID shot makers the hardest: reports
“Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to ...
Bread Recalled Over 'Glass Fragments' as FDA Warns Consumption Could Cause 'Adverse Health Consequences'
Bread and rolls sold in six states have been recalled over 'glass fragments,' according to the U.S. Food and Drug ...
Candy Recall Update as FDA Sets Risk Level
Milk not declared as an allergen was found in a Tennessee-based manufacturer's confectionery, not the first time candy has ...