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 ...
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 ...
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 ...
BioSpace2h
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 ...
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 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 ...
STAT1d
Will the FDA approve the first new drug to help people quit smoking in 20 years?
The drug cytisinicline could help expand options for quitting smoking, and if approved by the FDA, would be the first new ...
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 ...
FDA Approves Zevaskyn for Rare, Genetic Skin Disorder
Zevaskyn is the first and only autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa ...
The Manila Times15m
Nexalin Technology Initiates FDA Q-Submission Process for Gen-2 SYNC Following Encouraging Data and Preliminary FDA Feedback
The Company's decision to proceed with the Q-Sub follows recent publications, a review of new encouraging internal data, and ...