News

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 ...
Trump administration officials banned chosen names at FDA, NIH under new gender policy
Employees of the Food and Drug Administration and the National Institutes of Health are being told to use their legal names ...
FDA Approves Zevaskyn for Rare, Genetic Skin Disorder
Zevaskyn is the first and only autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa ...
US FDA chief says firings won't hinder agency's target dates for drug reviews
The U.S. Food and Drug Administration will meet its targets for completing reviews of new drugs despite mass firings at the ...
FDA chief looking at whether to approve COVID shots for next winter
The head of the Food and Drug Administration said Tuesday that the agency is now looking at whether it will still approve ...
MedPage Today on MSN22hOpinion
A Conversation With FDA Commissioner Marty Makary
Among other things, Makary breaks some news here by stating, for the first time, that there will be no significant ...
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 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 ...
The FDA’s ‘Bullish Signal’ to Biotech Could Backfire
The notion that we can simultaneously demand expedited approvals while gutting the agency is misguided.
Not so fast on the FDA’s food dye ban — the Supreme Court has changed the rules
The Supreme Court’s recent reversal of the Chevron doctrine means every new regulation is now living on borrowed time — and ...
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 ...
FDA Issues New Guidance For AI-Enabled Medical Devices: Why The Threats Are Real And Alarming
AI is a transformational force in healthcare, but without cybersecurity as its foundation, it becomes a high-stakes gamble.