News

Neuralink's speech restoration device gets FDA's 'breakthrough' tag
Neuralink has received U.S. Food and Drug Administration's 'breakthrough' tag for its device to restore communication for ...
FDA Commissioner: No Major Reorganization, Just Smart Reforms
In an exclusive interview with physician and writer Dr. Jeremy Faust on Substack, Makary opened up about his first weeks on ...
FDA to rehire fired staffers who booked inspection trips, but other workers remain in limbo
The Food and Drug Administration is again trying to rehire some staffers who were recently fired amid mass layoffs at the ...
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 ...
Fierce Pharma5h
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 ...
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 ...
BioSpace6h
FDA Misses Another Deadline Amid Staff Exodus, Structural Disruptions
The FDA has lost several senior employees in recent weeks, including some who have been at the agency for more than two ...
FDA to Require Placebo-Controlled Trials for Vaccine Approvals
The US Food and Drug Administration will require all new vaccines go through placebo-controlled studies before they are ...
FDA Recalls Bread Across the U.S. Due to ‘Glass Fragments Found’
The FDA is recalling hundreds of cases of bread due to contamination with “glass fragments.” Here is a list of impacted ...
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 ...
US FDA approves J&J's immune disorder drug
The U.S. Food and Drug Administration on Wednesday approved Johnson & Johnson's drug to treat a type of muscle-weakening ...
Fierce Biotech1h
Edwards Lifesciences nets FDA approval opening up TAVR to patients before they show symptoms
Edwards Lifesciences has claimed a groundbreaking approval from the FDA that opens up its minimally invasive heart valve ...