News

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 ...
BioSpace3h
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 ...
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 ...
Fierce Pharma1h
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 ...
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 ...
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 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 ...
UK's Genus secures FDA approval for PRP gene edit; shares soar
British animal genetics company Genus on Wednesday said the U.S. Food and Drug Administration (FDA) approved its PRP gene ...
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 suspends dairy quality testing amid federal workforce cuts. Is it safe to consume milk?
The testing of Grade A dairy products like pasteurized and raw milk, cheese, and yogurt are currently being paused by the FDA ...
manilatimes15h
FaceHeart Received Another FDA Clearance for its Contactless Video-Based Vital Sign Measurement of Respiratory Rate
Developed by FaceHeart, FH Vitals SDK-RR has obtained FDA Clearance. This is the second 510(k) class II SaMD (Software as a Medical Device) FaceHeart received from the FDA. FaceHeart Vitals™ is a ...
FDA issues urgent nationwide recall of bread sold in US found with 'glass fragments'
An urgent recall for hundreds of cases of frozen bread sold throughout the U.S. was issued after the FDA said "glass ...