News

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 ...
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 ...
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 ...
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 ...
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 ...
Fierce Pharma4h
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 ...
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 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 ...
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 ...
BioSpace5h
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 scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...
FDA Approves Zevaskyn for Rare, Genetic Skin Disorder
Zevaskyn is the first and only autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa ...