News

Neuralink's speech restoration device gets FDA's 'breakthrough' tag
(Reuters) -Neuralink has received the U.S. Food and Drug Administration's "breakthrough" tag for its device to restore ...
FDA to rehire fired staffers who booked inspection trips, but other workers remain in limbo
For the second time in recent months, the Food and Drug Administration is bringing back some recently fired employees, ...
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 ...
Ask a health professional: What does the FDA’s food dye phase-out mean for families?
New FDA regulations are changing what’s allowed in popular snacks and cereals. Here’s what families should know about ...
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 Pharma13h
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 ...
BioSpace14h
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 ...
National Law Review3h
Federal Court Strikes Down FDA Rule on LDTs
On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA ...
FDA to Mandate Placebo-Controlled Trials for New Vaccines
The US Food and Drug Administration will require all new vaccines to undergo placebo-controlled trials before approval — a ...
FDA Chief Says He Won’t Reorganize Agency After Mass Layoffs (1)
The FDA doesn’t plan to execute a reorganization of the agency but will consolidate offices that handle travel, technology, ...
FDA Approves Zevaskyn for Rare, Genetic Skin Disorder
Zevaskyn is the first and only autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa ...